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Nourkrin ® Woman with Marilex ® Enhances Hair Growth and Appearance and Improves Hair Confidence in Women with Diffuse Hair Loss from Brazil: An Investigator- initiated Clinical Study Clinical & Investigative Dermatology



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Citation: Mattos Simoes M, Thom E, Wadstein J. Nourkrin® Woman with Marilex® Enhances Hair Growth and Appearance and Improves Hair Condence
in Women with Diuse Hair Loss from Brazil: An Investigator-initiated Clinical Study. J Clin Investigat Dermatol. 2020;8(1): 4
J Clin Investigat Dermatol
July 2020 Volume 8, Issue 1
© All rights are reserved by Thom E, et al.
Nourkrin® Woman with
Marilex® Enhances Hair
Growth and Appearance and
Improves Hair Confidence in
Women with Diffuse Hair Loss
from Brazil: An Investigator-
initiated Clinical Study
Mattos Simoes M1, Thom E2* and Wadstein J3
1Av Brasil, 1438, suite 704, Funcionários, Belo Horizonte / Minas Gerais,
2ETC Research and Development, Oslo, Norway
3Research and Development, Wadlund A/S, Sweden
*Address for Correspondence
Thom E, Bjornveien 45A, 0774, ETC Research and Development,
Oslo, Norway, Tel: 47-91710137; E-mail:
Submission: 12 June 2020
Accepted: 20 July 2020
Published: 23 July 2020
Copyright: © 2020 Matto s Simoe s M, e t al. This is an open access article
distributed under the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original work is properly cited.
Research Article
Open Access
Journal of
Clinical & Investigative
Avens Publishing Group
Invi ting Innovations
community as a separate condition from androgenetic alopecia in
men (also known as Male Pattern Hair Loss (MPHL)). Hair loss is
unexpectedly common among women. Surveys indicate that the
lifetime prevalence of FPHL is more than 55% [1]. is means that
more than half of women would have to withstand the physical and
psychological consequences of hair loss at some point throughout
their life. Although hair loss is not a critical medical condition,
aected individuals oen experience signicant psycho-emotional
stress that may lead to impaired quality of life and morbid psychiatric
disorders, e.g. general anxiety and depression [2]. Hence, clinicians
are responsible for oering eective yet safe and sustainable treatment
options, specically to female patients who are more susceptible to
psycho-social complications of hair loss.
Detailed pathogeneses of TE, particularly its chronic form, and
FPHL are not yet fully disclosed. Despite its symptomatic overlap with
MPHL, FPHL is believed to be caused by a dierent set of aetiological
factors that still wait being determined. In any case, androgens do
not appear to be the sole driver of hair loss in FPHL, since it occurs
in individuals with complete androgen insensitivity syndrome
[3]. New insight has originated from the evidence suggesting that
‘proteoglycan dysmetabolism’ is a central aetiology in diuse hair loss
that connects the eect of external triggers to degenerative follicular
changes [4,5]. In aected hair follicles, the capacity to synthesize
specic proteoglycans is disturbed, and thus, the concentration of
bioactive proteoglycans at anagen is progressively declined. is
pathology is in clinical literature known as ‘Follicular Hypoglycania
(FHG)’ and causes a defective extracellular matrix, unable to support
the normal growth of follicular cells. Initial stages of FHG cause hair
shedding due to shortening of anagen and elongation of telogen
as in TE and the rst stages of FPHL. In the long term, untreated
FHG can lead to gross dysfunction and shrinkage of hair follicles,
known as ‘Proteoglycan Follicular Atrophy (PFA)’. PFA explains the
progressive thinning and miniaturisation of scalp hairs observed in
women with FPHL [4].
Recognising the causal roles of proteoglycans in hair loss and
Female Pattern Hair Loss (FPHL) and Telogen Euvium (TE)
are the most common forms of hair growth disorders in women.
Surprisingly, FPHL has just recently been recognised by the scientic
Keywords: Female pattern hair loss; Proteoglycans; Proteoglycan
replacement therapy; Nourkrin®; Marilex®; Patient outcome assessment;
Patient satisfaction; Self-condence
Background: Female Pattern Hair Loss (FPHL) and Telogen Effluvium (TE)
are common dermatological conditions in women, affecting half of the female
population. Treating hair loss in women is more challenging since its pathogenesis
is not fully understood and it commonly leads to more serious psychosocial
consequences compared to hair loss in men. Recent evidence highlights the
involvement of proteoglycan dysmetabolism and follicular hypoglycania as
a mediating pathology. Follicular hypoglycania disturbs cellular activity and
is behind the gradual deterioration of hair follicles, a condition known as
Proteoglycan Follicular Atrophy (PFA). Proteoglycan Replacement Therapy (PRT)
with Nourkrin® with Marilex® is a unique approach that helps to treat PFA and
restore a normal hair growth cycle.
Methods: We aimed to investigate the treatment satisfaction and subjective
efficacy of Nourkrin® with Marilex®. To this end, 67women with moderate to
severe FPHL or TE (mean age=42.73 years) were enrolled into an investigator-
initiated, subjective, cohort study carried out by practicing dermatologists in Brazil
in collaboration with the World Hair Council. Study participants were randomly
selected by several collaborating dermatologists and have voluntarily started a 6
month course of monotherapy with Nourkrin® Woman (600mg Marilex® per
day). They were interviewed every 3 months using a semi-structured questionnaire.
Results: Just after 3 months, 94.03% and 95.52% of participants reported
having experienced improved hair growth and appearance, respectively; and 83.58%
were more confident with their hair. All Nourkrin® users were satisfied with the
results at this point and were willing to continue with the treatment. At endpoint,
94.03% of subjects experienced enhanced hair growth and 92.54% reported
improved appearance of their hair. These positive changes have led 83.58% of
participants to feel more confident with their hair. Overall treatment satisfaction
rate with Nourkrin® therapy was 97.01%.
Conclusion: Our findings indicate that women with diffuse hair loss found
PRT with Nourkrin® an effective approach that stimulates hair growth and
improves hair appearance. Treated patients felt more self-confident and were
satisfied with Nourkrin® monotherapy.
Avens Publishing Group
Invi ting Innovations
Citation: Mattos Simoes M, Thom E, Wadstein J. Nourkrin® Woman with Marilex® Enhances Hair Growth and Appearance and Improves Hair Condence
in Women with Diuse Hair Loss from Brazil: An Investigator-initiated Clinical Study. J Clin Investigat Dermatol. 2020;8(1): 4
J Clin Investigat Dermatol 8(1): 4 (2020) Page - 02
ISSN: 2373-1044
thinning has led to the utilisation of proteoglycan-based therapies
as a novel approach to hair loss. e Originator Nourkrin® with
Marilex®(produced by Pharma Medico Aps, Aarhus, Denmark)
uses a specic combination of bioactive proteoglycans with ‘anagen
inducing’ and ‘anagen maintaining’ properties to mitigate FHG
and treat PFA. is unique method is referred to as ‘Proteoglycan
Replacement erapy (PRT)’ in clinical literature. Numerous clinical
trials and papers have conrmed and demonstrated the clinical
ecacy and safety of PRT with Nourkrin® in patients with diuse hair
loss [6-9].
In order to provide a more complete picture of the therapeutic
eects, tolerability and treatment satisfaction rate of PRT with
Nourkrin®, a clinical cohort study by practicing dermatologists
was carried out. We have strived in this research to elucidate how
the objective clinical improvements by Nourkrin® are subjectively
perceived by patients.
Materials and Methods
Study participants
e target population of the current study was female individuals
aged 18 to 65 years with non-inammatory diuse hair loss diagnosed
by a qualied clinician. Sampling was performed by independent
collaborating dermatologists in outpatient clinics across major cities
in Brazil, including Sao Paulo, Rio de Janeiro and Curitiba. During the
screening phase, 98 potential subjects were screened from which 74
were enrolled into the cohort phase of the study. Before recruitment,
clinicians gave detailed ecacy and safety information on the
Nourkrin® proteoglycan replacement therapy to eligible patients and
obtained their consent for participation. Extra information was also
provided regarding the availability of other therapeutic options.
e participants agreed to refrain from taking additional anti-
hair loss medications or supplements, undergoing laser treatment,
hair transplantation or other major surgical procedures involving the
scalp and maintain their usual hairstyling practices for the duration
of the study. Getting aected by a clinically signicant conditionor
taking medications known to aect hair growth (e.g. contraceptive
pills, anabolic steroids, immune modulators and cytotoxic or
cytostatic drugs) during or within six months prior to the study were
considered the criteria for exclusion. Pregnant and breastfeeding
women were also excluded from participation. Subjects with a known
allergy to sh or shellsh were not included as Nourkrin® Woman
contains sh-derived compounds.
Study Design. e present study was an open-label, long-term,
longitudinal cohort with two follow-up evaluations at month 3
and 6. All participants have voluntarily decided to start a 6-month
course of monotherapy with 2 tablets of Nourkrin® Woman (Pharma
Medico Aps, Aarhus, Denmark) per day. Each Nourkrin® Woman
tablet contains 300 mg of an active ingredient, Marilex®. Marilex® is
a proprietary natural extract rich in lecticans and small leucine-rich
proteoglycans with hair growth stimulating properties [4].
At baseline, a collaborating dermatologist interviewed each
potential subject and exerted a general medical and dermatological
evaluation. e severity of hair loss in each patient was graded using
Ludwig classication scale for FPHL [10]. Aer 3 and 6 months of
treatment, patients were asked to score the changes that occurred in
the growth, quality and appearance of their hair compared to baseline
as well as the eect of the treatment on their hair condence. For
each evaluation, a structured, self-administered, 2-point (yes or no)
questionnaire was used to assess participants’ self-perception and
overall treatment satisfaction. In addition, questions on the safety and
tolerability of Nourkrin® Woman were included in the questionnaires.
Clinical supervision and scientic consultation were generously
provided by the members of the World Hair Council (WHC)
throughout the study. WHC is a non-prot organization consisting
of trichologists, dermatologists and hair loss specialists dedicated
to improving the lives of people living with hair growth disorders
Out of 74 enrolled participants, 7 failed to report at 3-month time
point and thus were eliminated from the nal analysis. In this section,
Number of participants 67
Age (years), mean (range) 42.73 (18-64)
Grade of hair thinning/loss (number)
1 (Mild) 0
2 (Moderate) 35
3 (Severe) 32
Duration of hair thinning/loss (months), mean (range) 151 (2-300)
History of previous therapy (number)
Yes 49
No 18
Participants with a recent stressful period (%) 49.25%
Table 1: Baseline demographics of study participants.
Figure 1: Participants’ impression about various eects of treatment with
Nourkrin® Woman after 3 and 6 months as assessed by a 2-point scale
Citation: Mattos Simoes M, Thom E, Wadstein J. Nourkrin® Woman with Marilex® Enhances Hair Growth and Appearance and Improves Hair Condence
in Women with Diuse Hair Loss from Brazil: An Investigator-initiated Clinical Study. J Clin Investigat Dermatol. 2020;8(1): 4
J Clin Investigat Dermatol 8(1): 4 (2020) Page - 03
ISSN: 2373-1044
data from a per-protocol sample size of 67 is reported. (Table 1) below
presents a summary of baseline characteristics of study subjects. As
shown, participants were middle aged women with either moderate
(52%) or severe (48%) degrees of diuse hair loss. Despite having a
long history of the condition, more than one third of the patients
have not been diagnosed previously and never been oered an active
medical treatment. Almost half of the subjects reported being under
considerable psychological stress.
Recruited individuals have been asked to judge if Nourkrin®
therapy had a positive eect on their hair and if they feel more
condent with its appearance or not. e obtained results aer 3 and
6 months are illustrated in below (Figure 1). Noticeably, the majority
of women with advanced forms of diuse hair loss have reported
substantial enhancements in the growth and quality of their hair just
aer 3 months of Nourkrin® monotherapy. ese positive changes
resulted in improvements in hair satisfaction and condence in 84%
of the cases. Of note, all users (100%) were satised with PRT with
Nourkrin® and were willing to continue their treatment aer the rst
3 months.
At the end of the study period, more than 92% of treated patients
believed that Nourkrin® treatment had signicantly improved the
growth and appearance of their hair and 8 out of 10 users expressed
that they feel more condent with their hair than before the
treatment. When asked to score their treatment satisfaction, 9 out of
10 participants expressed their positive overall impression.
Participants were closely monitored during the course of the
study to detect any newly-onset symptoms or side eects. Six
individuals reported minor gastrointestinal, which were of no clinical
signicance and did not cause any study withdrawals.
e subjects under investigation in this study were a group of
women diagnosed with diuse scalp hair loss selected by qualied
dermatologists. Reviewing the medical records has brought into light
that around one third of the participants had not received any form
of medical treatment before participating in this study. is troubling
nding implies that many women with hair loss are le undiagnosed
and untreated, which roots in the current poor awareness of Female
Patten Hair Loss (FPHL) and Telogen Euvium (TE) among both
the public and healthcare professionals. However, even the patients
who are fortunate enough to get noticed and receive medical care are
frequently unsatised with the outcomes. Human trials have shown
that more than 50% of women with FPHL do not respond to 2%
topical minoxidil and are unsatised with this treatment [11].On the
other hand, nasteride is no more eective than placebo in women
with pattern hair loss [12]. Most patients participating in our study
represent the non-respondent, dicult-to-treat patients that are in
grave need for a novel and eective treatment.
Proteoglycan Replacement erapy (PRT) with Nourkrin®
is a veried novel therapeutic method that can either be used as a
monotherapy or be added to standard hair loss medications. Hence,
PRT has great potential to occupy an important position in standard
clinical management of hair loss in women, particularly with the
current paucity of eective medications. Marilex® is the active
ingredient in Nourkrin® Woman that comprises of a unique mixture
of marine-derived proteoglycans with hair growth stimulating
eects. A recently published, comprehensive review explains how
oral administration of Marilex® can regulate the hair growth cycle and
stimulate dormant hair follicles to start producing new hair [4]. In
two independent randomised, placebo-controlled, clinical trials, 6
months of PRT with Nourkrin® has signicantly increased hair density
by 32-36% in patients with pattern hair loss. Subjective assessments
also indicated a high rate of treatment satisfaction in Nourkrin® users
[6,7]. A later trial reported considerable improvements in overall
quality of life and all of its sub-scores aer adding Nourkrin® to the
treatment regimen of women with hair loss [9].
Aligned with the abovementioned objective ndings, it
was demonstrated in this study that Nourkrin®’s eects are also
subjectively perceived as positive and satisfactory by the patients and
lead to improvements in the self-esteem of aected women. Although
Nourkrin®’s minimum recommended treatment period is 6 months,
continuous use of Nourkrin® Woman for just 3 months produced
noticeable changes in hair growth and quality in more than 90% of the
users (immediate impact). Some experts believe that the immediate
impact of Nourkrin® is fundamentally due to the anagen-inducing
property of the bioactive proteoglycans abundantly found in Marilex®
[13,14]. Improvements in hair growth and appearance persisted
throughout the follow-up period and were judged as signicant by
the absolute majority of patients at the end of the study. is was
similar to a previous cohort study conducted in the United Kingdom,
which also revealed comparably high ecacy ratings and treatment
satisfaction with Nourkrin® [8]. One important clinical aspect of
positive patient impression is that not only treatment ecacy results
in higher satisfaction rates, but also patient satisfaction may contribute
to greater symptom resolution and actual disease improvement in a
reciprocal relationship [15].
Of note is that a large proportion of subjects in our study were
under psychological stress at the time of enrolment. It is proven
that stress can independently aggravate hair loss through triggering
an immature anagen termination, promoting telogen, inducing
follicular shrinkage and up-regulating apoptosis [16]. Positive eects
of Nourkrin® on patients’ self-image and self-condence is hence of
great therapeutic value and can indirectly reduce the severity of hair
shedding. Moreover, in conditions such as hair loss, the primal goal
of treatment is to reduce the psychosocial burden of the disease and
improve patients’ perceived self-image.
In the modern clinical management of hair loss, choosing a
therapeutic approach with an optimal safety/ecacy balance is of
utmost importance. Long-term administration of Nourkrin® Woman
in our study did not induce any side eects. is nding signies
the safety of Nourkrin® in treating women with diuse hair loss and
conrms the former observational and interventional clinical reports
Subjective outcomes of long-term PRT with Nourkrin® with
Marilex® were studied in the present longitudinal cohort study.
Participants were women with moderate-to-severe FPHL, selected
from dierent dermatology clinics in Brazil. Observations were
conclusive as to Nourkrin® therapy produces signicant improvements
Citation: Mattos Simoes M, Thom E, Wadstein J. Nourkrin® Woman with Marilex® Enhances Hair Growth and Appearance and Improves Hair Condence
in Women with Diuse Hair Loss from Brazil: An Investigator-initiated Clinical Study. J Clin Investigat Dermatol. 2020;8(1): 4
J Clin Investigat Dermatol 8(1): 4 (2020) Page - 04
ISSN: 2373-1044
in hair growth and appearance in more than 90% of the patients. 8
out of 10 participants stated that they had more condence in their
hair aer taking Nourkrin® and all volunteers were willing to continue
their PRT aer the rst 3 months of treatment. Patients’ satisfaction
rate was notably high at more than 97% aer both 3 and 6 months of
receiving Nourkrin®. Overall, our ndings imply that Nourkrin® is an
eective and safe hair loss treatment that oers tangible benets to
the patients and equips the clinicians with an extra tool to manage
hair loss in women.
1. Gan DC, Sinclair RD (2005) Prevalence of male and female pattern hair loss
in Maryborough. J Investig Dermatol Symp Proc 10: 184-189.
2. Hadshiew IM, Foitzik K, Arck PC, Paus R (2004) Burden of hair loss: stress
and the underestimated psychosocial impact of telogen euvium and
androgenetic alopecia. J Invest Dermatol 123: 455-457.
3. Cousen P, Messenger A (2010) Female pattern hair loss in complete
androgen insensitivity syndrome. Br J Dermatol 162: 1135-1137.
4. Wadstein J, Thom E, Gadzhigoroeva A (2020) The integral roles of specic
proteoglycans in hair growth and hair loss - Mechanisms behind the bioactivity
of Proteoglycan Replacement Therapy with Nourkrin® with Marilex® in pattern
hair loss and telogen euvium. Dermatol Res Pract 2020: 8125081.
5. Sonthalia S, Deepashree D, Antonella T (2016) Hair restoration in
androgenetic alopecia: looking beyond minoxidil, nasteride and hair
transplantation. J Cosmetol Trichol 2: 1-13.
6. Thom E (2001) Ecacy and tolerability of Hairgain in individuals with hair
loss: a placebo-controlled, double-blind study. J Int Med Res 29: 2-6.
7. Thom E (2006) Nourkrin: objective and subjective eects and tolerability in
persons with hair loss. J Int Med Res 34: 514-519.
8. Wadstein J, Thom E (2019) Treating Female Diuse Hair Loss using
Nourkrin® Woman (with Marilex®)-An Open-label, Subjective, Outcome
Study on Hair Growth and Appearance, Self-Condence and Treatment
Satisfaction. J Clin Dermatol Ther 5: 037.
9. Kingsley DH, Thom E (2012) Cosmetic hair treatments improve quality of life
in women with female pattern hair loss. J Appl Cosmetol 30: 49-59.
10. Ludwig E (1977) Classication of the types of androgenetic alopecia (common
baldness) occurring in the female sex. Br J Dermatol 97: 247-254.
11. Jacobs JP, Szpunar CA, Warner ML (1993) Use of topical minoxidil therapy
forandrogenetic alopecia in women. Int J Dermatol 32: 758-762.
12. van Zuuren EJ, Fedorowicz Z, Schoones J (2016) Interventions for female
pattern hair loss. Cochrane Database Syst Rev 26: CD007628.
13. Inui S, Itami S (2014) A newly discovered linkage between proteoglycans and
hair biology: Decorin act as an anagen inducer. Exp Dermatol 23: 547-548.
14. Jing J, Wu XJ, Li Yl, Cai SQ, Zheng M, et al. (2014) Expression of decorin
throughout the murine hair follicle cycle: hair cycle dependence and anagen
phase prolongation. Exp Dermatol 23: 486-491.
15. Dubina MI, O’Neill JL, Feldman SR (2009) Eect of patient satisfaction on
outcomes of care. Expert Rev Pharmacoecon Outcomes Res 9: 393-395.
16. Botchkarev VA (2003) Stress and the hair follicle: exploring the connection s.
Am JPathol 162: 709-712.
Authors would like to thank all the clinicians and assistants
who took part in the enrolment, evaluation and follow-up of the
patients in this study. We also extend our gratitude to Pharma
Medico Aps for supplying Nourkrin® Woman tablets and to the
members of World Hair Council for their tireless contributions.
ResearchGate has not been able to resolve any citations for this publication.
Full-text available
Follicular proteoglycans are key players with structural, functional, and regulatory roles in the growth and cycling behaviour of the hair follicles. The expression pattern of specific proteoglycans is strongly correlated with follicular phase transitions, which further affirms their functional involvement. Research shows that bioactive proteoglycans, e.g., versican and decorin, can actively trigger follicular phase shift by their anagen-inducing, anagen-maintaining, and immunoregulatory properties. This emerging insight has led to the recognition of “dysregulated proteoglycan metabolism” as a plausible causal or mediating pathology in hair growth disorders in both men and women. In support of this, declined expression of proteoglycans has been reported in cases of anagen shortening and follicular miniaturisation. To facilitate scientific communication, we propose designating this pathology “follicular hypoglycania (FHG),” which results from an impaired ability of follicular cells to replenish and maintain a minimum relative concentration of key proteoglycans during anagen. Lasting FHG may advance to structural decay, called proteoglycan follicular atrophy (PFA). This process is suggested to be an integral pathogenetic factor in pattern hair loss (PHL) and telogen effluvium (TE). To address FHG and PFA, a proteoglycan replacement therapy (PRT) program using oral administration of a marine-derived extract (Nourkrin® with Marilex®, produced by Pharma Medico Aps, Aarhus, Denmark) containing specific proteoglycans has been developed. In clinical studies, this treatment significantly reduced hair fall, promoted hair growth, and improved quality of life in patients with male- and female-pattern hair loss. Accordingly, PRT (using Nourkrin® with Marilex®) can be recommended as an add-on treatment or monotherapy in patients with PHL and TE.
Full-text available
Background: Female pattern hair loss (FPHL), or androgenic alopecia, is the most common type of hair loss affecting women. It is characterised by progressive shortening of the duration of the growth phase of the hair with successive hair cycles, and progressive follicular miniaturisation with conversion of terminal to vellus hair follicles (terminal hairs are thicker and longer, while vellus hairs are soft, fine, and short). The frontal hair line may or may not be preserved. Hair loss can have a serious psychological impact on women. Objectives: To determine the efficacy and safety of the available options for the treatment of female pattern hair loss in women. Search methods: We updated our searches of the following databases to July 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (2015, Issue 6), MEDLINE (from 1946), EMBASE (from 1974), PsycINFO (from 1872), AMED (from 1985), LILACS (from 1982), PubMed (from 1947), and Web of Science (from 1945). We also searched five trial registries and checked the reference lists of included and excluded studies. Selection criteria: We included randomised controlled trials that assessed the efficacy of interventions for FPHL in women. Data collection and analysis: Two review authors independently assessed trial quality, extracted data and carried out analyses. Main results: We included 47 trials, with 5290 participants, of which 25 trials were new to this update. Only five trials were at 'low risk of bias', 26 were at 'unclear risk', and 16 were at 'high risk of bias'.The included trials evaluated a wide range of interventions, and 17 studies evaluated minoxidil. Pooled data from six studies indicated that a greater proportion of participants (157/593) treated with minoxidil (2% and one study with 1%) reported a moderate to marked increase in their hair regrowth when compared with placebo (77/555) (risk ratio (RR) = 1.93, 95% confidence interval (CI) 1.51 to 2.47; moderate quality evidence). These results were confirmed by the investigator-rated assessments in seven studies with 1181 participants (RR 2.35, 95% CI 1.68 to 3.28; moderate quality evidence). Only one study reported on quality of life (QoL) (260 participants), albeit inadequately (low quality evidence). There was an important increase of 13.18 in total hair count per cm² in the minoxidil group compared to the placebo group (95% CI 10.92 to 15.44; low quality evidence) in eight studies (1242 participants). There were 40/407 adverse events in the twice daily minoxidil 2% group versus 28/320 in the placebo group (RR 1.24, 95% CI 0.82 to 1.87; low quality evidence). There was also no statistically significant difference in adverse events between any of the individual concentrations against placebo.Four studies (1006 participants) evaluated minoxidil 2% versus 5%. In one study, 25/57 participants in the minoxidil 2% group experienced moderate to greatly increased hair regrowth versus 22/56 in the 5% group (RR 1.12, 95% CI 0.72 to 1.73). In another study, 209 participants experienced no difference based on a visual analogue scale (P = 0.062; low quality evidence). The assessments of the investigators based on three studies (586 participants) were in agreement with these findings (moderate quality evidence). One study assessed QoL (209 participants) and reported limited data (low quality evidence). Four trials (1006 participants) did not show a difference in number of adverse events between the two concentrations (RR 1.02, 95% CI 0.91 to 1.20; low quality evidence). Both concentrations did not show a difference in increase in total hair count at end of study in three trials with 631 participants (mean difference (MD) -2.12, 95% CI -5.47 to 1.23; low quality evidence).Three studies investigated finasteride 1 mg compared to placebo. In the finasteride group 30/67 participants experienced improvement compared to 33/70 in the placebo group (RR 0.95, 95% CI 0.66 to 1.37; low quality evidence). This was consistent with the investigators' assessments (RR 0.77, 95% CI 0.31 to 1.90; low quality evidence). QoL was not assessed. Only one study addressed adverse events (137 participants) (RR 1.03, 95% CI 0.45 to 2.34; low quality evidence). In two studies (219 participants) there was no clinically meaningful difference in change of hair count, whilst one study (12 participants) favoured finasteride (low quality evidence).Two studies (141 participants) evaluated low-level laser comb therapy compared to a sham device. According to the participants, the low-level laser comb was not more effective than the sham device (RR 1.54, 95% CI 0.96 to 2.49; and RR 1.18, 95% CI 0.74 to 1.89; moderate quality evidence). However, there was a difference in favour of low-level laser comb for change from baseline in hair count (MD 17.40, 95% CI 9.74 to 25.06; and MD 17.60, 95% CI 11.97 to 23.23; low quality evidence). These studies did not assess QoL and did not report adverse events per treatment arm and only in a generic way (low quality evidence). Low-level laser therapy against sham comparisons in two separate studies also showed an increase in total hair count but with limited further data.Single studies addressed the other comparisons and provided limited evidence of either the efficacy or safety of these interventions, or were unlikely to be examined in future trials. Authors' conclusions: Although there was a predominance of included studies at unclear to high risk of bias, there was evidence to support the efficacy and safety of topical minoxidil in the treatment of FPHL (mainly moderate to low quality evidence). Furthermore, there was no difference in effect between the minoxidil 2% and 5% with the quality of evidence rated moderate to low for most outcomes. Finasteride was no more effective than placebo (low quality evidence). There were inconsistent results in the studies that evaluated laser devices (moderate to low quality evidence), but there was an improvement in total hair count measured from baseline.Further randomised controlled trials of other widely-used treatments, such as spironolactone, finasteride (different dosages), dutasteride, cyproterone acetate, and laser-based therapy are needed.
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Patterned hair loss (PHL) is one of the most commonly encountered problems for dermatologists. PHL at an early age is often cosmetically unacceptable, tends to be persistent and inflicts a profound negative impact on one's quality of life. Androgenetic alopecia (AGA) affects both genders in a distinctive pattern of hair loss from the scalp (MPHL for male PHL and FPHL or female PHL). The etiopathogenesis of AGA is complex, so far the major factor emphasized to be involved has been the undesirable androgen metabolism at the hair follicle level. In this review article, we shall dwell upon the relatively newly understood pathophysiological factors behind the genesis of AGA apart from the hormonal factors like the Wnt/β-catenin pathway, follicular micro-inflammation, prostaglandin imbalance, loss of extracellular matrix and oxidative stress. Based on the sound understanding of these factors we will be elaborating upon therapies for treatment of AGA beyong minoxidil, finasteride and hair transplantation. Amongst the therapeutic options discussed include topical 5alpha reductase (AR) inhibitors like finasteride, oral 5AR inhibitor – dual receptor antagonist dutasteride, botanical 5AR inhibitors, oral anti-androgens and estrogens for FPHL like spiranolactone, drospirenone etc. Wnt/β-catenin activators like topical valproic acid, hair stem cell based therapies, prostaglandin based therapies, tetrapeptides, nutritional and anti-oxidants and many more.
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This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of a new agent for the treatment of hair loss, based on a marine protein, minerals and vitamins. Sixty subjects with hair loss of different aetiologies participated in the 6-month blinded phase of the study. Objective assessments indicated that the treatment was effective and subjective assessments showed a statistically significant positive effect of treatment. Exposure to the active preparation for a further 6 months in an open phase indicated a further improvement in hair growth. Exposure of the patients previously treated with placebo to the active preparation for 12 months gave similar results. Tolerability was good and no side-effects were reported. The product investigated may provide an alternative to pharmacotherapy for the treatment of hair-loss problems in individuals with androgenic alopecia.
Hair is a significant component of physical attractiveness and body image. Therefore, losing hair often affects an individual's self-image, self-esteem, and overall quality of life. A study was designed to determine whether cosmetic hair appearance improvements produced any quality of life changes for women, even though no reversal of their female pattern hair loss (FPHL) would necessarily occur. A study to assess quality of life changes during the period that patients attended a trichology center was conducted over a 24 month period. Each participant attended the trichology center every 4-12 weeks. The participants were advised of lifestyle changes to help their overall hair condition and given topical products and other treatments to help improve the cosmetic look of their hair loss problems. All participants were given the Kingsley Alopecia Profile (KAP) to complete at the initial consultation (month 0). The questionnaire was also given after six months of cosmetic treatments. The KAP is a valid and reliable 38 statement questionnaire which measures the effects of genetic alopecia on quality of life. The results demonstrated significant overall and subcategory (i.e., anxiety and depression, self- esteem, and psychosocial) improvements in quality of life after 6 months of treatment (p < 0.0001 ). This improvement in quality of life is indicated by a lower KAP and/or KAP subcategory score. The importance of hair loss on an individual's general quality of life should not be underestimated. This study has confirmed the results of many previous studies that FPHL has a major effect on the psychosocial and emotional well-being of women. With the lack of a reliable medical cure, chronic concerns of hair loss can lead to long term psychological problems. Therefore, the importance of a measurement which can quantify this impact for practitioners, thereby enabling them to treat the patient effectively, cannot be underrated. Topical trichology stimulants as well as a product1 based on a proprietary marine ingredient2 from Pharma Medico Group1, as used in this study, for treatment of FPHL have been shown to be of great value with respect to hair growth as well as the global improvement of the quality of life.
Proteoglycans have been suggested to play pivotal roles in hair biology. Decorin is a prototypical member of the small leucine-rich proteoglycan family, which is involved in numerous biological processes. However, the role of decorin in the hair cycle has not been elucidated. Moreover, the effects of decorin on the activities of many growth factors are complex and it is hard to predict whether decorin would affect hair growth or the hair cycle positively or negatively. Jing et al. focused on the potential role of decorin in the hair cycle and found that decorin is highly expressed in the epidermis, in hair follicle epithelial cells and in dermal papilla cells in the anagen phase. The expression of decorin was decreased during catagen to telogen, except for the bulge region. Exogenous administration of decorin accelerated anagen and delayed catagen transition as a positive regulator of the hair cycle. Because TGF-β is one of androgen-induced pathogenic factors in androgenetic alopecia, this study provides clues to understand the pathogenesis and new therapeutic targets of hair loss. This article is protected by copyright. All rights reserved.
Female pattern hair loss, also known as female androgenetic alopecia, is generally regarded as an androgen-dependent disorder representing the female counterpart of male balding. We describe female pattern hair loss occurring in a patient with complete androgen insensitivity syndrome suggesting that mechanisms other than direct androgen action contribute to this common form of hair loss in women.
Androgenetic alopecia in the female occurs much more frequently than is generally believed. The condition is still considered infrequent, for it differs, in its clinical picture and in the sequence of events leading to it, from common baldness in men. To facilitate an early diagnosis (desirable in view of the therapeutic possibilities by means of antiandrogens) a classification of the stages of the common form (female type) of androgenetic alopecia in women is presented. The exceptionally observed male type of androgenetic alopecia can be classified according to Hamilton or to the modification of this classification proposed by Ebling & Rook.
Androgenetic alopecia is the most common cause of hair loss in men and women. Androgenetic alopecia in women begins as a diffuse and progressive thinning of the frontoparietal area of the scalp. In women, hair loss at any age is socially unacceptable and may be the basis of psychiatric illness. A 32-week, double-blind, placebo-controlled trial was conducted in 10 European centers to assess the efficacy and safety of 2% topical minoxidil solution for the treatment of androgenetic alopecia in women. Two hundred ninety-four of the 346 women enrolled (85%) completed the 32-week trial. Photographic and computer imaging techniques were used at each visit to determine objectively the number of nonvellus hairs present in a 1-cm2 area selected as the target evaluation site. In the 2% minoxidil group, the mean increase in nonvellus hair count was 33 hairs, which was significantly greater than that of 19 hairs in the placebo group (P = 0.0001). The investigators observed that 44% of the patients in the 2% minoxidil group achieved new hair growth compared with 29% in the placebo group. When asked to evaluate their own hair growth, 55% of the women in the 2% minoxidil group compared to 41% of the women in the placebo group believed that they had achieved new hair growth. No clinically significant changes in vital signs were observed during the study and no serious or unexpected medical events were reported. Topical minoxidil solution was significantly more effective than placebo in the treatment of androgenetic alopecia in women.