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Use of Er:YAG Laser in the Treatment of Vulvar Lichen Sclerosus

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Objective: The aim of this research was to evaluate the efficacy and safety of Er:YAG lasers to improve signs and symptoms of vulvar lichen sclerosus. Methods: The study population consisted of 28 women with symptomatic vulvar lichen sclerosus. Three nonablative, thermal-only Er:YAG laser treatment sessions (7 J/cm2, 2 Hz, 7 mm spot) were performed at 4-week intervals. Each patient was asked about the presence of symptoms, such as itching, pain, and coital pain. Clinical diagnosis was established on the basis of the presence of lesions such as hypopigmentation, ecchymosis, hyperkeratosis, excoriations, or fissures. The affected areas were divided by zones (clitoris, introitus, labia minora, labia majora, perineum, labial fusion, and effacement) and were visually evaluated. Based on the presence of symptoms, lesions, and affected zones, a scale with a maximum of 14 scores was established for use before and after treatment. The impact of lichen sclerosus on patients' lives before and after treatment was evaluated with an 11-point visual analogue scale, and treatment discomfort was assessed at each session. Results: After analysis of each scoring component, individual statistically significant reductions were observed in itching, pain, ecchymosis, excoriations, and hypopigmentation. Conclusion: The Er:YAG laser is a safe, well tolerated, and effective method for the adjuvant treatment of vulvar lichen sclerosus. Three sessions with monthly intervals using the indicated parameters can quantifiably reduce the impact of lichen sclerosus on patients' lives.
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Original Research
Use of Er:YAG laser in the treatment of vulvar lichen sclerosus
Matilde Gómez-Frieiro, MD
*
, Elena Laynez-Herrero, MD
Gabinete Médico Ginecológico, Santa Cruz de Tenerife, Spain
article info
Article history:
Received 15 November 2018
Received in revised form 17 May 2019
Accepted 24 May 2019
Keywords:
erbium laser
vulvar lichen sclerosus
abstract
Objective: The aim of this research was to evaluate the efficacy and safety of Er:YAG lasers to improve
signs and symptoms of vulvar lichen sclerosus.
Methods: The study population consisted of 28 women with symptomatic vulvar lichen sclerosus. Three
nonablative, thermal-only Er:YAG laser treatment sessions (7 J/cm
2
, 2 Hz, 7 mm spot) were performed at
4-week intervals. Each patient was asked about the presence of symptoms, such as itching, pain, and coi-
tal pain. Clinical diagnosis was established on the basis of the presence of lesions such as hypopigmen-
tation, ecchymosis, hyperkeratosis, excoriations, or fissures. The affected areas were divided by zones
(clitoris, introitus, labia minora, labia majora, perineum, labial fusion, and effacement) and were visually
evaluated. Based on the presence of symptoms, lesions, and affected zones, a scale with a maximum of 14
scores was established for use before and after treatment. The impact of lichen sclerosus on patients’ lives
before and after treatment was evaluated with an 11-point visual analogue scale, and treatment discom-
fort was assessed at each session.
Results: After analysis of each scoring component, individual statistically significant reductions were
observed in itching, pain, ecchymosis, excoriations, and hypopigmentation.
Conclusion: The Er:YAG laser is a safe, well tolerated, and effective method for the adjuvant treatment of
vulvar lichen sclerosus. Three sessions with monthly intervals using the indicated parameters can quan-
tifiably reduce the impact of lichen sclerosus on patients’ lives.
Ó2019 Published by Elsevier Inc. on behalf of Women’s Dermatologic Society. This is an open access
article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction
Vulvar lichen sclerosus is a chronic inflammatory dermatologic
disease of autoimmune origin that is characterized by a lympho-
cytic response with a predilection for the skin of the genital area.
It can affect both sexes and has an association with different
autoimmune diseases (Murphy, 2010). Although vulvar lichen scle-
rosus can manifest extra-genitally, in women, the disease appears
predominantly in the vulvar area. According to age distribution,
vulvar lichen sclerosus is more frequent around the sixth decade
of life. Symptoms and signs include itching, dryness, and irritation;
consequently, the genital/sexual sphere of patients is affected by
the appearance of dysuria and coital pain (Guerra, 2010). Histolog-
ically, the disease is characterized by epidermal atrophy, hyperker-
atosis, follicular plugging, degeneration of the basal layer, and a
band of subepidermal hyalinization of collagen in the papillary
dermis above a lymphocytic infiltrate (Pérez-López and Vieira-
Baptista, 2017).
The current first-line treatment of lichen sclerosus is symp-
tomatic, aimed at palliating symptoms and delaying the recurrence
of lesions (Neill et al., 2010). The effectiveness of topical clobetasol
in improving the symptoms of lichen sclerosus has been demon-
strated by chronic application with rest periods (Diakomanolis
et al., 2002). However, the long-term use of high-potency corticos-
teroids can lead to skin thinning (Renaud-Vilmer et al., 2004). This
has led to the search for alternative therapies, often aimed at being
complementary treatments to corticosteroids. Drugs such as cal-
cineurin inhibitors already have their place in the therapy of lichen
sclerosus. Other techniques, such as the use of the CO
2
lasers, are
justified by the repair effect of the lesion area after creating an
ablative effect on the skin by stimulating the affected tissue from
the adjacent edge in the subsequent healing (Baggish, 2016;
Fillmer et al., 2009; Kartamaa and Reitamo, 1997; Lee et al.,
2016). The application of platelet-rich plasma (Behnia-Willison
et al., 2016) and the transfer of autologous fat (Onesti et al.,
2016; Tonnard et al., 2013) are other alternatives to this treatment
within the regenerative therapy group.
The use of lasers in gynecology has been investigated for more
than 50 years, with the application of this technique to treat cervi-
cal and vaginal pathology and even pelvic pathology and fertility.
https://doi.org/10.1016/j.ijwd.2019.05.007
2352-6475/Ó2019 Published by Elsevier Inc. on behalf of Women’s Dermatologic Society.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Corresponding Author.
E-mail address: matildegomez@gamegin.es (M. Gómez-Frieiro).
International Journal of Women’s Dermatology 5 (2019) 340–344
Contents lists available at ScienceDirect
International Journal of Women’s Dermatology
In recent years, the application of energy to the vaginal walls in a
controlled manner has been observed to stimulate neovasculariza-
tion, the proliferation of glycogen, and the formation of collagen in
the lamina propria, which leads to an increase in natural lubrica-
tion and basal tone and thereby improves urinary incontinence
and vaginal hypermobility by improving the biomechanical condi-
tions of the vaginal mucosa (Gambacciani and Cervigni, 2015;
2017; Gambacciani and Levancini, 2015; Gaspar and Brandi,
2017; Gaspar et al., 2017; Jung et al., 2015; Lee, 2014; Vizintin
et al., 2015). There are published reports about the benefits of non-
ablative Erbium lasers in the treatment of vaginal relaxation syn-
drome (Lee, 2014), mild-to-moderate stress urinary incontinence
(Gaspar and Brandi, 2017; Vizintin et al., 2015), and the genitouri-
nary syndrome of menopause (Gambacciani and Cervigni, 2015;
Gambacciani and Levancini, 2015, 2017; Gaspar et al., 2017). The
Er:YAG laser with specific nonablative modality, which causes
shrinkage of collagen fibers and consequently triggers neocollage-
nesis, might be another therapeutic option for lichen sclerosus,
where an alteration in the distribution of collagen is very impor-
tant (Drnovsek-Olup et al., 2004; Farkas et al., 2010; Lins et al.,
2010; Pereira et al., 2002; Poon et al., 2005; Schmitt et al., 2017).
The indicated nonablative application of the Er:YAG laser lasts
for 250 milliseconds and consists of a fast sequence of ultra-
short pulses of 300 microseconds with intervals of 50 milliseconds.
In this way, the temperature in the mucosa can be increased
between 60°and 65°C without inducing superficial ablation. At
this temperature, collagen is denatured, which creates short colla-
gen fibers that function as a stimulus of fibroblasts; neocollagene-
sis begins to occur and happens within a maximum of 6 weeks. The
activation of procollagen I and III, interleukin 1-beta, tumor necro-
sis factor alpha, tumor necrosis factor beta-1, and metallopro-
teinases has been shown to explain this effect in low-dose lasers
(Drnovsek-Olup et al., 2004; Farkas et al., 2010; Lins et al., 2010;
Pereira et al., 2002; Poon et al., 2005; Schmitt et al., 2017).
The aim of this study is to evaluate the effect of Er:YAG laser
application on the impact of lichen sclerosus on the lives of women
diagnosed with vulvar lichen sclerosus, assessing parameters such
as extension, symptoms, clinical signs, scale of impact on life, and
tolerance to treatment.
Methods
Patients
A total of 28 patients with a clinically confirmed diagnosis of
vulvar lichen sclerosus were recruited from a gynecology clinic in
Santa Cruz de Tenerife (Gabinete Médico Ginecológico), a private
practice with a database of 23,500 patients at present. Diagnoses
were not histologically confirmed. The study protocol was con-
ducted in accordance with the Declaration of Helsinki. Written
informed consent was obtained from all patients. The inclusion cri-
teria included women age >18 years who were diagnosed with vul-
var lichen sclerosus; did not have problems with writing, reading,
or verbal comprehension; and had provided written informed con-
sent. The exclusion criteria included women with contraindica-
tions for the use of laser on the skin, those who did not sign
informed consent, or had no clear diagnosis of vulvar pathology.
At the first visit, a clinical history was obtained and any other
pathology and contraindication ruled out. Each patient was asked
about the presence of symptoms such as itching, pain, and coital
pain, and all positive responses were assigned a score of one point.
The presence of clinical signs such as hypopigmentation, ecchymo-
sis, hyperkeratosis, excoriations, or fissures were observed and
given one point if present. The affected areas were divided by
zones (clitoris, introitus, labia minora, labia majora, and perineum),
and a point was assigned to each affected zone. A photograph was
taken before treatment, and the affected area was confirmed if
there was effacement or labial fusion. A summary of the symptoms
and clinical findings established a score that ranged from 0 (mini-
mal effect) to 14 points (maximum effect). A visual analogue scale
was used to assess the impact of lichen sclerosus on patients’ lives,
with 0 being no impact and 10 the maximum impact.
Laser treatment
First, the affected area was anesthetized with Emla anesthetic
cream (lidocaine 25 mg/g + prilocaine 25 mg/g). In the first session,
the Er:YAG laser (SP Dynamis, Fotona, Slovenia) was applied with a
PS03 handpiece with fluence of 7 J/cm
2
, 2 Hz, and spot of 7 mm in
continuous application, making several passes that exceed the lim-
its of the affected area. A special Er:YAG treatment modality
(Fotona SMOOTH mode) that causes gentle coagulative heating of
the skin was used. The modality delivers laser energy onto the skin
in a fast sequence of low-fluence laser pulses inside an overall
super-long pulse of 200 ms to 350 ms. Every so often when the
area whitened, it was cleaned with gauze soaked in physiologic
fluid. The objective was to achieve uniform whitening and an
increase in local heat until erythema of the area or whitening
was observed after 10 minutes of application. Three sessions were
applied in monthly intervals. After each session, the patient was
instructed to use Palomacare vulvar gel, an external moisturizer
with hyaluronic acid, Asiatic spark, bioecolia (alpha aminoglucan),
and aloe vera, for 3 days after treatment to calm possible discom-
fort in the area.
After the procedure, patient tolerance to the treatment was
assessed via a questionnaire with four options (i.e., very tolerable,
tolerable, slightly tolerable, and unacceptable). One month after
the last session, the patient was summoned for a final survey
and documentary verification by means of a photograph of the
treated area, which was added to the database.
Statistical evaluation
All data were collected through the public domain program EPI
INFO, which was designed by the Centers for Disease Control and
Prevention of Atlanta and allows building databases and analyzing
them for epidemiological studies. Means and standard deviations
were calculated to describe the quantitative variables, and medi-
ans were measured to describe the variables deemed not normal
according to the Kolmogorov-Smirnov test. For the comparison of
scales, the nonparametric Wilcoxon test was performed, and the
McNemar’s test was used to compare each parameter of the total
score before and after treatment. A p-value of < .05 was considered
significant. The analyses were done with SPPS version 24.
Results
The average age of patients was 58.4 years (range: 29-78 years).
Twenty-six of 28 patients had previously been pregnant, and 23
patients were menopausal. Twenty-two of 28 patients maintained
regular sexual activity, and 6 patients did not have sexual relations
due to the discomfort of their pathology. With regard to previous
treatments with corticosteroids, 23 of 28 patients reported having
had treatment on occasion, and 5 patients had never received
treatment. Patients who had received corticosteroids suspended
treatment a month before initiating Erbium laser treatment and
did not resume treatment until 1 month after the last Erbium laser
treatment,when the final assessment was made. Patients who had
never received corticosteroid treatment were either never treated
M. Gómez-Frieiro, E. Laynez-Herrero / International Journal of Women’s Dermatology 5 (2019) 340–344 341
until they reached the office and had not been diagnosed or did not
want to take corticosteroid agents.
The total score assigned to each patient before treatment ran-
ged from a minimum of 5 to a maximum of 14 (Fig. 1). The mean
value was 9.3 with a standard deviation of 2.51. One month after
the end of the three scheduled sessions, the score ranged from a
minimum of 0 to a maximum of 10, with a mean value of 4.36
(standard deviation: 2.34; Fig. 1). The most frequent symptom
before treatment was itching (82.1% of patients), pain
(60.7%), and coital pain (50.0%). After-treatment itching was pre-
sent in 14.3%, pain in 3.6%, and coital pain in 25.0% of patients
(Fig. 2).
The mean visual analogue scale score of the impact of lichen
sclerosus on patients’ lives and the mean values of the total score
decreased significantly after treatment (Table 1). Tolerance to
treatment varied between very tolerable (57.14%), tolerable
(35.71%), slightly tolerable (7.14%), or unacceptable (0%).
Statistically significant differences from before to after treat-
ment were observed with symptoms such as itching and vulvar
pain, but not coital pain, although a relationship between coital
pain and a higher final score was found (Table 2). The following
clinical signs showed statistically significant improvement after
treatment: ecchymosis, excoriations, and hypopigmentation.
Although some improvement in labial fusion and hyperkeratosis
was detected, the improvement was not statistically significant.
No improvement was seen in effacement (Figs. 3 and 4).
Discussion
To our knowledge, no report of Erbium laser treatment for vul-
var lichen sclerosus has been published to date, except for a case
report that describes the application of fractional laser on extra-
genital lichen sclerosus (Mendieta-Eckert et al., 2017) and a letter
on two cases with hyperkeratotic lichen sclerosus treated with
fractionally ablative Erbium laser (Hobson et al., 2019). In the case
of extragenital lichen sclerosus, the patient showed no symptoms
and clinical response even after 2 years of follow up.
The results of this study showed that Er:YAG laser treatment
significantly reduces symptoms of lichen sclerosus such as itching
and vulvar pain, but not coital pain. Improvement after treatment
was significant in clinical signs (ecchymosis, excoriations, and
hypopigmentation), and some improvement was detected in labial
fusion and hyperkeratosis. No improvement was observed in
effacement. Laser treatment was well tolerated by patients and sig-
nificantly reduced the impact of lichen sclerosus on patients’ lives.
Some limitations of the study include the lack of a control
group, the possibility of a placebo effect, and the subjective assess-
ment of symptoms (e.g., itching, pain, and coital pain) because
Fig. 2. Symptoms frequency before and after treatment.
Table 1
Comparison of impact of lichen sclerosus on patients’ lives and total score before and
after treatment
Mean (Standard deviation) Median p-value
Impact before treatment 5.36 (2.25) 5.5 < .0001
Impact after treatment 1.57 (1.4) 2
Total score before treatment 9.32 (2.51) 10 < .0001
Total score after treatment 4.36 (2.34) 4
The impact of lichen sclerosus on patients’ life before and after treatment was
assessed with a 0 to 10 visual analogue scale. The minimum value before treatment
was 2 and the maximum was 10. After treatment the minimum was 0 and the
maximum was 6. Contrast by Wilcoxon test.
Table 2
Comparison by component of total score before and after Er:YAG treatment
Before After p-value
Itching No 5 24 < .0001
Yes 23 4
Vulvar pain No 11 27 < .0001
Yes 17 1
Coital pain No 12 21 .146
Yes 13 7
Hypopigmentation No 2 12 .006
Yes 26 16
Ecchymosis No 8 23 < .0001
Yes 20 5
Hyperkeratosis No 21 23 .625
Yes 7 5
Excoriations No 11 24 .001
Yes 17 4
Introitus No 1 10 .004
Yes 27 18
Labia minora No 3 11 .008
Yes 25 17
Clitoris No 5 11 .002
Yes 23 17
Labia majora No 11 22 .001
Yes 17 6
Perineum No 2 16 .001
Yes 24 12
Labial fusion No 20 23 .375
Yes 8 5
Effacement No 17 17 .999
Yes 11 11
There are significant differences [p< .05] for all parameters with the exception of
coital pain, hyperkeratosis, presence of labial fusion, and effacement. Contrast with
McNemar’s test.
Fig. 1. Total score for the presence of symptoms, clinical signs, and affected areas
before treatment and 1 month after the last treatment session.
342 M. Gómez-Frieiro, E. Laynez-Herrero / International Journal of Women’s Dermatology 5 (2019) 340–344
these depend on assessment by the patient and the other 11
parameters depend on assessment by the attending physician.
Also, the initially striking results of a reduction in impact of lichen
sclerosus on patients’ lives can be attributed to patient bias
because this was not a double-blinded study and may have
involved a desire to collaborate with the doctor. Additionally, his-
tology could also benefit the confirmation of a clinical diagnosis,
but its inclusion in an adult lichen sclerosus severity scale is ques-
tionable (Sheinis and Selk, 2017). Analyzing biopsy test result
changes to treatment may be objective, but whether this outcome
is important to patients is unclear and likely should be used as an
adjunct to other measures (Sheinis and Selk, 2017).
In addition, some patients may have associated genitourinary
syndrome of menopause along with lichen sclerosus, but that
was not a factor of exclusion in this study. Per our protocol, we
did not treat the vagina but only the vulvar area, and the treatment
Fig. 3. Reduction of white lesions on the sides of the introitus before (left) and after (right) treatment.
Fig. 4. Improvement in skin quality before (left) and after (right) treatment.
M. Gómez-Frieiro, E. Laynez-Herrero / International Journal of Women’s Dermatology 5 (2019) 340–344 343
of genitourinary syndrome of menopause was not expected. For
patients who responded to both pathologies, any improvement
amounted to an additional benefit of treatment. Future work
should consider what energy dose is the most effective; in our
study we started from a choice based on tolerability by the patient
and response to these fluences in other benign cutaneous patholo-
gies, such as atrophy, scars, or stretch marks. The number of ses-
sions applied and the intervals required to obtain the best results
should also be considered. Further controlled clinical studies with
larger sample sizes and longer follow-up are necessary to confirm
the preliminary results of the effectiveness of Er:YAG laser treat-
ment of this pilot study and provide standardization of parameters.
Conclusion
The Er:YAG laser is a good method for treatment of vulvar
lichen sclerosus supplementary to topical steroids. Three sessions
with monthly intervals with the indicated parameters provided a
quantified reduction in the impact of lichen sclerosus on patients’
lives. Most patients in this study had previously used topical corti-
costeroids, and treatment with the Er:YAG laser additionally
reduced symptoms and clinical signs. Unifying criteria and descrip-
tion of the treatment guidelines for the specific lasers applied are
important to obtain consistent results and improve the quality of
future studies.
The Er:YAG laser opens a very interesting field in the regenera-
tive treatment of chronic pathologies, and we encourage doctors
who have this technology to use it as a complementary and safe
alternative that has proven effective in reducing the impact of
lichen sclerosus on a woman’s life.
Acknowledgments
The authors thank Professor Stephany Hess from the Depart-
ment of Clinical Psychology, Psychobiology, and Methodology of
the Faculty of Health Sciences of the University of La Laguna;
Mrs. Yolanda Ramallo Fariña, Biostatistics of the Evaluation Service
of the Canary Islands Health Service and advisor of the Official
College of Physicians of Tenerife; and colleagues from the Expert
Course in Functional Aesthetic Gynecology and Intimate Surgery
of Women at the University of Barcelona, Spain.
Conflict of Interest
None.
Funding
None.
Study Approval
NA.
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... Of nine single arm trials, [23][24][25][26][27][28][29][30][31] seven were studies of women with vulval LS and two included men with genital LS. 26,31 The intervention was ablative Er:YAG laser in 1 study, non-ablative Er:YAG in 1 study, 24,27 and fractional CO 2 laser 6, with ablative CO 2 in one. One study using fractional (sub-ablative) CO 2 had additional treatment with autologous plasma and immunity modulation with nutrition factors. ...
... Of nine single arm trials, [23][24][25][26][27][28][29][30][31] seven were studies of women with vulval LS and two included men with genital LS. 26,31 The intervention was ablative Er:YAG laser in 1 study, non-ablative Er:YAG in 1 study, 24,27 and fractional CO 2 laser 6, with ablative CO 2 in one. One study using fractional (sub-ablative) CO 2 had additional treatment with autologous plasma and immunity modulation with nutrition factors. ...
... There were some clinical improvements observed including: visible improvement in skin colour, elasticity and vascularity, reduced elasticity, atrophy and fissures, 26 significant improvement of ecchymosis, excoriations and hypopigmentation 27 and improved whitening, elasticity and lichenification, although moderate to severe labial fusion improved in only four of the 11 subjects. 28 Symptoms that were reported to improve include itching, [23][24][25]27,29,30 vulvar discomfort, pain or soreness, 23,24,27 dryness, burning, bleeding, easy tears and ulcerated lesions. ...
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Background Lichen sclerosus (LS) is a chronic, inflammatory dermatosis. Initial treatment with superpotent topical corticosteroids is the accepted and evidence-based first-line therapy. For those who do not respond after exclusion of other potentiating factors, the best second-line therapy is unclear. Laser therapy is an emerging treatment for genital LS and despite uncertain efficacy its use is gaining popularity in the private sector. Objectives We aimed to review the effectiveness of laser therapy for genital LS in men, women and children. Methods We conducted a systematic review of all primary studies reporting the use of laser in genital LS. Ovid MEDLINE, PubMed, Ovid Embase, Cochrane CENTRAL, Web of Science, CINAHL and PsycINFO were searched from inception to February 2021. The quality of the studies was assessed using the revised Cochrane risk-of-bias tool for randomized trials, ROBINS-I tool for non-randomized trials and Joanna Briggs Institute checklist for case studies. Results A total of 24 studies, involving 616 adults, met inclusion criteria. These were six randomized controlled trials (RCTs), one non-randomized trial, nine single arm trials and eight case series. Where assessed, most studies suggest that laser therapy in patients with LS may improve symptoms, clinical signs, quality of life and sexual function. However, results were highly heterogeneous and methodological quality was very low, therefore meta-analysis was not possible. Conclusions There is poor evidence to support the use of laser therapy for genital LS at present. Effectiveness of laser needs to be robustly investigated in well-conducted RCTs.
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Vulvar lichen sclerosus (LS) is a chronic vulvar dermatosis potentially impacting quality of life and sexual function. While most women with LS respond to topical corticosteroids and/or calcineurin inhibitors, some require additional therapy. Systemic therapies have been used successfully in oral and vulvovaginal lichen planus with minimal data in the setting of LS. Likewise, while vaginal laser therapy has shown potential benefit for genitourinary syndrome of menopause, there is a paucity of data in the setting of LS. We review retrospective and prospective studies along with randomized controlled trials utilizing vulvovaginal laser for LS therapy.
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Objective: To estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus. Methods: We conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus). Results: From November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI -1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI -0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI -1.14, 1.06, P=.76). Conclusion: Fractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus. Clinical trial registration: ClinicalTrials.gov, NCT03665584. Funding source: Additional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.
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Lichen planus (LP) is a mucocutaneous immune-mediated disease of unknown etiology. It is more prevalent in women and usually occurs between the third and sixth decades of life. Oral lesions may or may not be associated with skin and genital lesions. Although the role of genetic factors is still undetermined, reports of LP in more than one family member are not uncommon. However, the occurrence of LP in monozygotic twins is rare. We report a rare case of 42-year-old female monozygotic twins presenting oral LP. This report is even rarer because one of the patients had cutaneous lesions of an unusual variant of LP (LP pigmentosus) and the other had an uncommon association with lichen sclerosus. The etiology and pathogenesis of LP are still uncertain. However, despite being rare, its occurrence in family members and monozygotic twins suggests that genetic factors are involved in its development.
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Transvaginal laser therapies are being increasingly used for a variety of indications, particularly genitourinary syndrome of the menopause and stress urinary incontinence. This article reviews the current data pertaining to the place of these devices in current clinical practice. Whilst there has been a rapid increase in the number of publications over the last few years, many of the studies are of small numbers, short duration, and poor quality and are device-sponsored. The evidence suggests that vaginal laser therapy with either the erbium-doped yttrium aluminum garnet laser (FotonaSmooth®) or the CO2 laser (MonaLisa Touch®) is an effective intervention for the relief of symptoms of vulvovaginal atrophy in symptomatic women. The benefits of three laser treatments appear to last for at least 12 months and the procedure is generally well tolerated, with transient minor discomfort being the most common adverse event. Whilst the vaginal laser certainly has the potential to be an alternative treatment to vaginal estrogens for those groups of women, such as breast cancer patients, who cannot take them, there are still many unanswered questions about the role of vaginal laser therapy in clinical practice, particularly in relation to standard conservative management. The place of vaginal laser therapy in other conditions such as stress urinary incontinence is less clear. The outcomes from several ongoing randomized trials should help to answer some of these questions. In the meantime, the use of vaginal laser devices should be confined to clinical trials.
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The use of lasers to treat gynaecological and urogynaecological conditions including genitourinary syndrome of the menopause, stress urinary incontinence, vaginal prolapse and other conditions, has become increasingly popular over recent years. Following widespread concerns over the use of mesh for treating stress urinary incontinence and pelvic organ prolapse and potential adverse outcomes from the use of mesh, there has been heightened awareness and debate over the introduction and adoption of new technologies and interventions within the speciality. On July 30th 2018 the United States Food and Drug Administration (FDA) issued a warning against the use of energy based devices (EBDS) including laser to perform "vaginal rejuvenation" or vaginal cosmetic procedures. Numerous review articles and editorials have urged for greater evidence on the efficacy and safety of vaginal lasers This review outlines the evidence to date for the use of lasers in the treatment of gynaecological conditions.
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Objective: To generate a list of items through international expert consensus consisting of both symptoms and clinical signs for inclusion in an adult vulvar lichen sclerosus severity scale. Methods: This study was carried out as a three-stage Delphi consensus exercise. After an extensive literature review, any items used to determine disease severity in previous clinical trials were compiled into a survey. The Delphi participants were recruited from the International Society for the Study of Vulvovaginal Disease most of whom were gynecologists and in practice for more than 20 years. Participants were asked to rate the importance of these items. Consensus was defined as 75% agreeing that an item was very important or essential toward determining disease severity. Participants were also asked to indicate preferred method of measurement for these items. Results: Of approximately 400 members of the International Society for the Study of Vulvovaginal Disease, 66 participated in the study. Of the 14 symptoms presented, 7 reached consensus for inclusion. Of the 23 signs presented, 11 reached consensus for inclusion and 1 reached consensus for exclusion. Of the six architectural changes presented, all six reached consensus for inclusion. No consensus was reached regarding method of measurement for any of the symptoms and signs that reached consensus for inclusion. Conclusion: International consensus was reached for a variety of items for use in an adult vulvar lichen sclerosus severity scale that will be further developed and tested. Ideally, this scale will be used in clinical practice and in research to allow for high-quality trials.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
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The molecular changes in gene expression following ablative laser treatment of skin lesions, such as atrophic scars and UV-damaged skin, are not completely understood. A standardized in vitro model of human skin, to study the effects of laser treatment on human skin, has been recently developed. Therefore, the aim of the investigation was to examine morphological and molecular changes caused by fractional ablative erbium:YAG laser treatment on an in vitro full-thickness 3D standardized organotypic model of human skin. A fractional ablative erbium:YAG laser was used to irradiate organotypic human 3D models. Laser treatments were performed at four different settings using a variety of stacked pulses with similar cumulative total energy fluence (60 J/cm2). Specimens were harvested at specified time points and real-time PCR (qRT-PCR) and microarray studies were performed. Frozen sections were examined histologically. Three days after erbium:YAG laser treatment, a significantly increased mRNA expression of matrix metalloproteinases and their inhibitors (MMP1, MMP2, MMP3, TIMP1, and TIMP2), chemokines (CXCL1, CXCL2, CXCL5, and CXCL6), and cytokines such as IL6, IL8, and IL24 could be detected. qRT-PCR studies confirmed the enhanced mRNA expression of IL6, IL8, IL24, CXCLs, and MMPs. In contrast, the mRNA expression of epidermal differentiation markers, such as keratin-associated protein 4, filaggrin, filaggrin 2, and loricrin, and antimicrobial peptides (S100A7A, S100A9, and S100A12) as well as CASP14, DSG2, IL18, and IL36β was reduced. Four different settings with similar cumulative doses have been tested (N10%, C10%, E10%, and W25%). These laser treatments resulted in different morphological changes and effects on gene regulations. Longer pulse durations (1000 μs) especially had the strongest impact on gene expression and resulted in an upregulation of genes, such as collagen-1A2, collagen-5A2, and collagen-6A2, as well as FGF2. Histologically, all treatment settings resulted in a complete regeneration of the epidermis 3 days after irradiation. Fractional ablative erbium:YAG laser treatment with a pulse stacking technique resulted in histological alterations and shifts in the expression of various genes related to epidermal differentiation, inflammation, and dermal remodeling depending on the treatment setting applied. A standardized in vitro 3D model of human skin proved to be a useful tool for exploring the effects of various laser settings both on skin morphology and gene expression during wound healing. It provides novel data on the gene expression and microscopic architecture of the exposed skin. This may enhance our understanding of laser treatment at a molecular level.
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The objective of this pilot study was to determine the safety and efficacy of a new non-ablative erbium YAG laser procedure for the treatment of type III stress urinary incontinence (intrinsic sphincter deficiency) in women. Twenty-two patients with a Valsalva leak point pressure less than 60 cm H2O were recruited and treated with a non-ablative erbium laser delivering low fluence pulses inside the whole length of the urethra through a specially designed cannula. Treatment consisted of two treatment sessions with a 3-week interval in-between. Therapeutic efficacy, as assessed by a questionnaire addressing quality of life during urinary incontinence and the 1-h pad test, was measured at 3 and 6 months after the procedure. Both methods of assessment showed similar levels of improvement in terms of incontinence severity and improvement in quality of life. All patients tolerated the therapy well and adverse effects were mild and transient. The results of this pilot study showed significant improvement of type III stress urinary incontinence. Despite the limitations of this study, being small patient number and short follow-up, this non-ablative intraurethral erbium YAG laser procedure seems to be a safe and efficacious alternative for patients with type III stress urinary incontinence. More controlled studies should be performed to confirm this data and to evaluate the long-term effects.
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Background Lichen sclerosus (LS) is an inflammatory dermatosis with autoimmune pathogenesis. Although relatively common, its true incidence is unknown and likely underestimated. LS is usually anogenital, but in around 10% of patients, it can present as extragenital lesions. Continuous administration of topical corticosteroids is the mainstay of medical treatment. Other treatments are available but are only occasionally prescribed along with or instead of topical steroids. Injection of platelet-rich plasma (PRP) into affected areas has been reported to result in the regeneration of normal skin. In this study, we aimed to evaluate the safety, symptom resolution, and objective improvement in patients with autoimmune condition like genital LS after treatment with PRP. Methods Over a 2-year period at FBW Gynaecology Plus, we had a total of 28 patients with confirmed LS on biopsy, unresponsive to topical steroid treatment. After acquiring informed consent, patients’ own blood was centrifuged on site and injected under local anesthesia to the external genitalia. Results Almost all of our patients showed clinical improvement in the size of their lesions, and in 8 cases, lesions totally disappeared after treatment with PRP. Symptoms disappeared in 15 of the 28 patients after treatment, with no need for further steroid therapy in 23 patients. Thirteen women experienced partial symptom relief. Conclusions Based on our limited findings, we hypothesize that PRP presents a potential alternative to topical steroids for treatment of vulvovaginal autoimmune conditions such as LS. A larger pilot and/or randomized controlled trial study is required to evaluate this finding further.
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Objectives: The objective of this prospective comparative cohort study was to establish the effectiveness and safety of Erbium:YAG (Er:YAG) laser treatment for genitourinary syndrome of menopause and to compare it with an established topical estriol treatment. Methods: Fifty patients with genitourinary syndrome of menopause were divided into two groups. The estriol group received a treatment of 0.5 mg estriol ovules for 8 weeks and the laser group was first treated for 2 weeks with 0.5 mg estriol ovules 3 times per week to hydrate the mucosa and then received three sessions with 2,940 nm Er:YAG laser in non-ablative mode. Biopsies were taken before and at 1, 3, 6, and 12 months post-treatment. Maturation index, maturation value and pH where recorded up to 12-months post-treatment, while the VAS analysis of symptoms was recorded up to 18 months post-treatment. Results: Statistically significant (P < 0.05), reduction of all assessed symptoms was observed in the laser group at all follow-ups up to 18 months post-treatment. Significant improvement in maturation value and a decrease of pH in the laser group was detected up to 12 months after treatment. The improvement in all endpoints was more pronounced and longer lasting in the laser group. Histological examination showed changes in the tropism of the vaginal mucosa and also angiogenesis, congestion, and restructuring of the lamina propria in the laser group. Side effects were minimal and of transient nature in both groups, affecting 4% of patients in the laser group and 12% of patients in the estriol group. Conclusions: Our results show that Er:YAG laser treatment successfully relieves symptoms of genitourinary syndrome of menopause and that the results are more pronounced and longer lasting compared to topical estriol treatment. Lasers Surg. Med. © 2016. The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.
Article
Lichen sclerosus (LS) is a chronic condition affecting the anogenital region in women. Symptoms range from none at all to severe pruritus. While most LS is atrophic and culminates in scarring, there is a less common variant that is hyperkeratotic. This presentation is typically refractory to standard-of-care super-potent topical steroids, likely owing to decreased penetration. On rare occasions, if left partially or completely untreated, LS can progress to squamous cell carcinoma, highlighting the importance of monitoring and treating this condition.¹ We report 2 cases women with hyperkeratotic LS refractory to conventional treatment with super-potent topical steroids that was successfully treated with fractionally ablative laser therapy (Er:YAG; erbium-doped yttrium aluminium garnet).
Article
Female lichen sclerosus is a chronic inflammatory dermatitis, with a predilection for the anogenital area, which in some cases can become seriously distorted (atrophy of the labia minora, phimosis, introital stenosis, etc.). Most cases are diagnosed in postmenopausal women, but it can affect women of any age. Lichen sclerosus is usually a pruriginous condition, although it can also be asymptomatic. It is associated with an increased risk of vulvar cancer, even though it is not a premalignant condition itself. The true precursor of cancer associated with lichen sclerosus is vulvar intraepithelial neoplasia, differentiated type. The diagnosis is usually clinical, but in some cases a biopsy can be performed, especially to exclude vulvar intraepithelial neoplasia or cancer. The treatment of lichen sclerosus aims at controlling the symptoms, stopping further scarring and distortion and reducing the risk of cancer. The gold standard in treatment is ultra-potent topical steroids (clobetasol propionate). Second-line treatments include calcineurin inhibitors, retinoids, and immunosuppressors. Surgery is used only for the treatment of complications associated with lichen sclerosus. Follow-up must be kept indefinitely.
Article
Lichen sclerosus et atrophicus (LSA) is a chronic inflammatory disease of unknown cause that typically affects the genital area¹. It has been reported in post-traumatic areas as a result of Koebner´s phenomenon. LSA responds poorly to treatment making it a therapeutic challenge². Laser therapy has been described for LSA with variable results3,4.
Article
Objectives: The aim of this research was to assess the efficacy of fractional CO2 laser energy for treating vaginal atrophy and lichen sclerosus. Materials and Methods: The first study population was 23 postmenopausal women diagnosed with vaginal atrophy via microscopic evaluation and who were symptomatic. The second study population was 27 postmenopausal women diagnosed with lichen sclerosus by biopsy and who were symptomatic. Patients with vaginal atrophy had 3 treatment sessions spaced at 4–6 weeks between each session. Laser settings for this group were: power: Watts, 30; time, 1000 microseconds; and spacing, 1000 micrometers. For the lichen sclerosus group, the power was set at 20 Watts and 3–4 treatments were given at 4–6-week intervals. Results: In the vaginal atrophy cohort, 22/23 women who previously complained of dryness and discomfort had these symptoms alleviated and vaginal microscopic exam showed significant changes in color, elasticity, and wetness following 3 courses of CO2 laser fractional treatment; additionally 20/23 women had elimination of urinary frequency and urgency, 18/21 women had alleviation of dyspareunia. In the lichen sclerosus cohort 24/27 patients who had laser treatment reported cessation of itching and pain/discomfort; and 26/27 women demonstrated visible improvement of skin color, elasticity, vascularity following 3-4 laser treatments. All examinations were performed with the operating microscope. Conclusions: The fractional CO2 laser beam is useful for treating vaginal atrophy and lichen sclerosus. This new technique represents a significant divergence from estrogenic-, steroid- and corticosteroid-bulwark dependence. All treatments were performed in an office setting and were associated with either no pain or, at the most, minimal and temporary discomfort. This new use of the CO2 laser is an excellent alternative for managing these two troublesome problems, particularly in postmenopausal women. (J GYNECOL SURG 32:309)
Article
Objective: The aim of this study was to evaluate the efficacy and acceptability of a second generation of vaginal laser treatment, the vaginal erbium laser, as a nonablative photothermal therapy for the management of genitourinary syndrome of menopause in postmenopausal breast cancer survivors. Methods: The study was performed using an erbium laser crystal yttrium-aluminum-garnet (XS Fotona Smooth, Fotona, Ljubljana, Slovenia) with a wavelength of 2,940 nm. Forty-three postmenopausal breast cancer survivors were treated with three laser applications every 30 days. Symptoms were assessed before the treatment and after 1, 3, 6, 12, and 18 months, using two methods, subjective Visual Analog Scale (VAS) and objective Vaginal Health Index Score (VHIS). The procedures were performed on an outpatient basis without anesthesia or drug use before or after the intervention. Results: From baseline values of 8.5 ± 1.0 cm, vaginal dryness VAS scores were 4.4 ± 1.2 cm after the third treatment and 5.5 ± 1.5 cm 12 months after the treatment (P < 0.01 vs basal values), whereas they were 7.5 ± 1.8 cm after 18 months from the last laser application (NS vs basal values). From baseline values of 7.5 ± 1.5 cm, dyspareunia VAS values decreased to 4.2 ± 0.9 cm after the third treatment and 5.1 ± 1.8 cm 12 months from the last laser application (P < 0.01 vs basal values), whereas they were 6.5 ± 1.8 cm after 18 months from the last laser application (NS vs basal values). VHIS, from baseline values of 8.1 ± 1.3, was 21.0 ± 1.4 after the third treatment and 18 ± 1.8 12 months from the last laser application (P < 0.01 vs basal values), whereas they were 14.8 ± 1.5 cm after 18 months from the last laser application (NS vs basal values). No adverse events were recorded during the study. Conclusions: This study suggests that the vaginal erbium laser is effective and safe for the treatment of genitourinary syndrome of menopause in breast cancer survivors.