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An Evaluation of Theraphy with Fluconazole 150 mg Tablets Compared to Fluconazole 150 mg Tablets Plus Dermoxen Lenitiva Cream in The Time to Reduce Simptomatology in Women with Vulvovaginal Candidiasis

Authors:
  • Ekuberg Pharma
  • Italian National Research Council

Abstract and Figures

Aim of the study. Authors investigated first of all the time to onset of first relief of symptoms. Secondary measures included the time to overall relief of symptoms and the reoccurrence rate over the first 45 days after the first visit. Methods. A randomized, open-label, parallel study evaluated 47 women with moderate to severe symptoms of Vulvo Vaginal Candidiasis (VVC). Patients were divided into two groups of treatment: group 1 followed a therapy with Fluconazole 150 mg tablets, while group 2 had a therapy based on Fluconazole 150 mg tablets coadjuvated by Dermoxen Lenitiva cream. Results. The time at which 50% of patients experienced first relief of symptoms was 24.6 hours for Group 1, while for Group 2 it was 12.4 hours (P
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The Open Access Journal of Science and Technology AgiAl Publishing House
Vol.2 (2014), Ar ticle ID 101078, 4pages http://www.agialpress.com/
doi:10.11131/2014/101078
Clinical Study
An Evaluation of Theraphy with Fluconazole 150 mg
Tablets Compared to Fluconazole 150 mg Tablets Plus
Dermoxen Lenitiva Cream in The Time to Reduce
Simptomatology in Women with Vulvovaginal Candidiasis
Davide Carati1, Valentina Russo1, Marcello Guido2, Antonella Zizza3, Marcella Megha4,
Malvasi Antonio5, and Andrea Tinelli6
1Research & development department, Ekuberg Pharma srl, Martano (LE), Italy
2Laboratory of Hygiene, Department of Biological and Environmental Sciences and Technologies, Faculty of Sciences, University
of Salento, Lecce, Italy
3Institute of Clinical Physiology, National Research Council, Lecce, Italy
4Laboratory of Clinical Pathology, PoliambulatoryCittadella della saluteLecce, Italy
5Department of Obstetrics and Gynaecology, Santa Maria Hospital, Bari, Italy
6Department of Obstetrics and Gynecology, Vito Fazzi Hospital, Lecce, Italy
Corresponding Author: Davide Carati; email: davide.carati@ekubergpharma.com
Received 23 January 2014; Accepted 4 April 2014
Academic Editor: Osama Ibrahim Azawi
Copyright © 2014 Davide Carati et 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.
Abstract. Aim of the study. Authors investigated first of all the time to onset of first relief of symptoms. Secondary measures
included the time to overall relief of symptoms and the reoccurrence rate over the first 45 days after the first visit. Methods. A
randomized, open-label, parallel study evaluated 47 women with moderate to severe symptoms of Vulvo Vaginal Candidiasis
(VVC). Patients were divided into two groups of treatment: group 1 followed a therapy with Fluconazole 150 mg tablets, while
group 2 had a therapy based on Fluconazole 150 mg tablets coadjuvated by Dermoxen Lenitiva cream. Results. The time at which
50% of patients experienced first relief of symptoms was 24.6 hours for Group 1, while for Group 2 it was 12.4 hours (𝑃 < 0.05).
There were significant differences between the two groups in respect to the time of first relief of symptoms and reoccurrence
of infection within 45 days of treatment. Conclusions. Combined treatment with Fluconazole 150mg tablets and by Dermoxen
Lenitiva cream provides statistically significant improvement in the time of first relief of symptoms, complete relief of symptoms
and relapse time in the treatment of VVC compared to fluconazole 150 mg tablets only.
Keywords: Fluconazole, Dermoxen, vulvovaginal candidiasis, vaginitis
1. Introduction
Recurrent vulvovaginal candidiasis (RVVC) is a debilitating
chronic infectious condition. It is defined as four or more
acute inflammatory episodes of Vulvo Vaginal Candidosis
(VVC), also known as vaginal yeast infection, within a year
[1, 2]. The Candida albicans spp. has been known to be
the main responsible organism for RVVC, accounting for
80%–85% of cases. The other cases are due to non-albicans
species, with C. glabrata being the most common. Its
frequency has nearly doubled over the last ten years, and it has
been shown to account for 5%–15% of RVVC [3–5]. Other
non-albicans species also include C. tropicalis (<5%) and
C. krusei (about 1%) [6]. It has been estimated that 75% of
2The Open Access Journal of Science and Technology
all women will experience at least one episode of VVC, and
approximately 40% to 50% reporting a reoccurrence during
their lifetime [7]. The main symptoms of yeast infection are
inflammation, itching, an abnormal vaginal discharge and
painful sexual intercourse and urination [8–11]. All these
symptoms often cause severe discomfort, reducing quality of
life of women and their partner. Acute inflammatory episodes
are usually treated with antifungal drugs of the azole class.
They are effective in clearing the acute infection, but they
are unable to prevent recurrences, which occur on average
after a few months only. Vulvovaginal candidiasis has been
associated with considerable direct and indirect economic
costs [12], enhanced susceptibility to HIV infection [13],
and it is being investigated for a potential relationship with
preterm birth [14]. Fluconazole is the only orally available
imidazole with approved labeling specific for the treatment
of VVC. The recommended therapy is a single 150 mg
oral tablet. Many clinical studies have compared a single
fluconazole 150 mg oral tablet with a number of different
antifungal vaginal topical and suppository preparations.
Review of these studies suggests that the overall cure rate
with fluconazole 150 mg tablets is similar to that seen with
other preparations [15–23]. Moreover Dermoxen Lenitiva
cream, a topical formulation based on natural actives, was
found to be active against itching [24], often present in
women suffering from VVC, and useful to improve intimate
comfort and well-being during sexual intercourse.
The purpose of this study was to compare the time of
first relief of symptoms due to VVC, evaluating the results
of two study groups: group 1 followed a therapy with Flu-
conazole 150 mg tablets while group 2 had a therapy based
on Fluconazole 150 mg tablets plus Dermoxen Lenitiva, a
soothing intimate cream produced by Ekuberg Pharma srl
(Martano, Lecce- Italy). Moreover, the time for complete
relief of symptoms and reoccurrence rate were evaluated,
following up patients for 45 days after the end of treatment.
2. Materials and Methods
Authors developed a pilot, open-label, randomized study,
conducted according to Declaration of Helsinki and approved
by an Institutional review Board. Before to start, the protocol
and informed consent were reviewed, approved and signed by
the patients. Authors enrolled, from July 2013 to November
2013, 47 women who had symptoms of VVC, attending the
Department of Gynaecology and Obstetrics of University
affiliated Hospital “Vito Fazzi” (Lecce, Italy). Confirmation
of current VVC infection was made by use of KOH wet mount
preparation, pelvic examination and patient’s reporting of
signs and symptoms. The exclusion criteria for such study
were: patients suspected of having a concurrent vaginal
infection (i.e., bacterial vaginosis, trichomoniasis, herpetic
lesions); women with menstruation or women who know
menstrual cycle comes within two days; patients with a his-
tory of use of intravaginal or systemic antifungal medication
or other intravaginal products (spermicide, douche, spray,
gel, cream); women with a medical history of allergies or
intolerance to any of the active or non-active ingredients
of the study formulations. The symptomatology was eval-
uated using a scale from 0 (no symptoms) to 10 (severe
symptoms) for itching, redness, burning and dryness. Details
of last sexual intercourse, last menstrual period, method of
contraception, recent treatment, parity, contact’s symptoms
and relevant past history were all recorded. After diagnosis
by microscopy, the patients were treated randomly with
two types of treatment: Group I (𝑁 = 24) was treated
with Fluconazole 150 mg tablets (one tablet per day, for
two weeks), Group II (𝑁 = 23) with a therapy based on
Fluconazole 150 mg tablets plus Dermoxen Lenitiva cream
(one tablet and one application of cream per day, for two
weeks). Patients were recommended to record the time of
dosing. The main indication was to follow the treatment in
the early afternoon for a better evaluation of first relief of
symptoms. Patients were given a personal diary in which they
were requested to record the date and time they first started
to feel relief of symptoms, and the date and time they had
complete relief of symptoms. In this diary patients had to
notice any adverse events or concomitant medications. Seven
days after the end of the treatment, patients were required
to return to hospital for a follow-up visit, during which the
investigators checked the diary. 45 days after the end of the
treatment, patients were required to return another time to
hospital to investigate any case of relapse. The first outcome
of the study was the time of first relief of symptoms. The
second outcome of the study was the evaluation of complete
relief of symptoms and of any case of relapse, and their time
of appearance.
2.1. Statistical analysis. Two independent reviewers col-
lected, reported and classified data. Baseline demographics
(age, number of episodes of VVC in the previous 12 months
and severity score) were tabulated and compared using
descriptive statistics. Time of first relief of symptoms for each
patient was calculated using the relative dosing time and the
time reported for first relief of symptoms by each patient.
Analysis of these data was performed using Kaplan–Meier
estimates and 95% Confidence Interval analysis. 𝑃values
less than 0.05 were considered statistically significant.
3. Results
In this pilot study, 47 women with recognized VVC were
treated with two different protocols and included in two
groups: Group I (𝑁 = 24) and Group II (𝑁 = 23). A total of
77 patients (33 in group I and 44 in Group II) were eligible
for inclusion during first visit; 30 women were excluded
according to exclusion criteria (9 in Group I and 21 in Group
II). The analysis of demographic data was similar between
the two groups (Table 1).
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The Open Access Journal of Science and Technology 3
Table 1: Demographic data.
Group I (𝑁 =
24)
Group II(𝑁 =
23)
𝑃
Age (mean ±
SD)
34.4 ±6.6 34.1 ±8.1 0.2540
Parity (mean ±
SD)
1.1 ±1.0 1.2 ±1.0 0.6430
Both forms of treatment were effective in reducing the
signs and symptoms of vaginal candidiasis. All patients in
both groups had not registered any adverse events in their
diary.
In Table 2 the percentage of patients who recorded first
symptoms relief within the first 48 hours is reported. Patients
of Group II experienced first relief of symptoms with a higher
percentage in comparison with those of Group I at all time
points. Fifty percent of patients of Group I experienced first
symptom relief within 24.6 hours versus 12.4 of Group II
(𝑃 < 0.05). The median time for total relief was 77.3
hours for Group I and 64.3 for Group II (𝑃 < 0.05).
Evaluating patients of both groups after 45 days from the
end of the treatment, a total of 5 patients (20.83%) of Group
I experienced a reoccurrence of VVC, versus one patient
(4.34%) of Group II (𝑃 < 0.05).
4. Discussion
This study involved 47 women with recognized VVC , treated
with two different protocols and included in two groups:
Group I (𝑁 = 24) and Group II (𝑁 = 23). Both proposed
treatments registered an improvement in vaginal symptoms.
Combined treatment with Fluconazole 150 mg tablets plus
Dermoxen Lenitiva cream (one tablet and one application
of cream per day, for two weeks) showed a significant
improvement compared to the treatment with Fluconazole
150 mg tablets only, about time of first relief of symptoms of
VVC. In fact, fifty percent of patients of Group II experienced
first relief of symptoms after 12.4 hours versus 24.5 hours of
Group I. It has been estimated that 24 hours is a reasonable
period of time in order to evaluate general effectiveness
of therapy for VVC. For Group I, 49 % experienced first
symptom relief after 24 hours, versus 74.4% for Group II
(𝑃 < 0.05). This is an important result coming out from
the study, because it suggests that a combined “oral and
topical” treatment is more effective in relieving symptoms
of VVC than oral or topical treatment only. Total relief was
achieved after 77.3 hours for Group I and 64.3 for Group
II. No adverse events were registered in both groups. In
particular, in this study the oral treatment was administered
to defeat the infection, using fluconazole, because the main
objective of any therapy for the treatment of vaginal can-
didiasis is the eradication of the infecting organism; while
the topical treatment was specifically addressed to reduce
the symptomatology regarding itching, redness, burning of
Table 2: Time (hours) of first symptom relief.
Hours
after
dosing
Group I
Cumulative
%(𝑁 = 24)
Group II
Cumulative %
(𝑁 = 23)
𝑃value
(*statistically
significant)
2 2.9 11.7 𝑃 < 0.05∗
4 9.1 22.3 𝑃 < 0.05∗
6 12.5 27.0 𝑃 < 0.05∗
8 19.2 34.9 𝑃 < 0.05∗
10 24.0 45.2 𝑃 < 0.05∗
12 24.0 48.3 𝑃 < 0.05∗
14 32.8 57.1 𝑃 < 0.05∗
16 35.1 57.1 𝑃 < 0.05∗
18 39.4 64.6 𝑃 < 0.05∗
20 44.4 64.6 𝑃 < 0.05∗
22 46.7 69.0 𝑃 < 0.05∗
24 49.0 74.4 𝑃 < 0.05∗
26 51.1 77.7 𝑃 < 0.05∗
28 51.1 80.0 𝑃 < 0.05∗
30 55.6 80.0 𝑃 < 0.05∗
32 61.5 82.9 𝑃 < 0.05∗
34 61.5 82.9 𝑃 < 0.05∗
36 69.8 82.9 𝑃 < 0.05∗
38 76.0 82.9 𝑃 < 0.05
40 78.0 85.6 𝑃 < 0.05
42 81.8 90.4 𝑃 < 0.05∗
44 85.9 92.0 𝑃 < 0.05
46 88.0 93.6 𝑃 < 0.05
48 88.0 95.0 𝑃 < 0.05
external intimate area in terms of time. Another outcome of
this study was to evaluate the reoccurrence time, monitoring
patients of both groups for 45 days from the first visit: a total
of 5 patients (20.83%) of Group I experienced a reoccurrence
of VVC, versus one patient (4.34%) of Group II (𝑃 <
0.05). This is another important result, which needs better
investigation in order to understand if and how Dermoxen
Lenitiva cream could have a coadjuvant action against yeast
(action not presented by the product). Definitively, combined
treatment with Fluconazole 150 mg tablets plus Dermoxen
Lenitiva cream (one tablet and one application of cream
per day, for two weeks) more rapidly achieves first relief of
symptoms of VVC, compared to Fluconazole 150 mg tablets
only, reducing cases of RVVC.
5. Conclusion
Combined treatment with Fluconazole and Dermoxen Leni-
tiva cream should be considered as an important first line
therapy in patients presenting the signs and symptoms
of VVC and RVVC. A trial involving more patients and
more outcomes, may guarantee a better investigation of this
| http://www.agialpress.com/
4The Open Access Journal of Science and Technology
finding, taking care of extending the time of follow up to 90
days.
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In patients with vulvovaginal mycosis systemic treatment is being discussed for eradication of possible fungal reservoirs, therefore, the efficacy and toleration of fluconazole, a triazole-derivative, has been investigated in the course of an open, comparative study. 104 patients with clinical, microscopic and cultural evidence of vaginal mycosis were included, 53 of whom were treated with a single dose of 15 0 mg of fluconazole and 51 patients daily received local treatment with 50 mg of econazole over a period of 6 days. The results regarding clinical efficacy were comparable for both preparations. At follow-up visits 4 to 10 d and 30 to 45 d post therapy the mycological as well as the subjective cure rates were similar. However, there was a higher mycological cure rate in the rectum of fluconazole patients which was statistically verifiable. This enables the elimination of rectal fungal infection as a source of homologous reinfection.
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For sporadic acute Candida vaginitis, any oral or local antifungal therapy can be used. For women with recurrent vulvo-vaginal candidosis (RVC), on the other hand, such simple approaches are insufficient, regardless of the product chosen. Instead, RVC should be managed as any other chronic disease and requires long-term, prophylactic, suppressive antifungal treatment. A regimen using individualized, decreasing doses of oral fluconazole (the ReCiDiF regimen) was proven to be highly efficient and offered great comfort to the patients. During this regimen, it is crucial that patients are carefully examined by anamnestic, clinical, microscopic and culture-proven absence of Candida. If a relapse occurs, the medication is adjusted and efforts are taken to find a possible triggering factor for the reactivation of the infection. Care has to be taken not to accumulate 'don't do's', unless the efficiency of a measure has been proven, by trying to eliminate one risk factor at a time for 2 months. Known possible triggers to be kept in mind are (1) antibiotic use, (2) use of specific contraceptives, especially combined contraceptive pills, (3) disturbed glucose metabolism, (4) the use of personal hygienic products, and (5) tight clothing or plastic panty liners. In therapy-resistant cases, non-albicans infection must be ruled out, and alternative therapies should be tried. Boric acid is proven to be efficient in most of these resistant cases, but other non-azoles like amphotericin B, flucytosine, gentian violet, and even caspofungin may have to be tried. As a final remark it has to be said that many patients feel poorly understood and inefficiently managed by many care-givers, increasing their feelings of guilt and sexual inferiority. Therefore, attention has to be given to take the disease seriously, follow strict treatment regimens, and advise precisely and based on individual evidence concerning any possible risk factors for recurrence. In case of therapy-resistant vulvo-vaginitis, reconsider your diagnosis and/or consider referral to specialized therapists.
Article
Candida genus has various species. The incidence of C. glabrata has presented itself with more frequency over the past years with clinical importance. A case study was made to determine the frequency of C. glabrata in 468 patients who presented clinical symptomatology for vulvovaginal candidiasis and the in vitro response for fluconazole using two methods: diffusion in agar plates and microdilution in liquid medium [NCLSI (NCCLS) method]. The frequency for this specie was 12.6%, almost double the frequency observed 10 years ago. The resistance of C. glabrata to fluconazole treatment was confirmed in this study, representing 68.2% resistance in all strains on test plates and 51.2% on NCLSI method with a MIC of 16 microg/ml. Conclusions: The frequency of Candida glabrata has increased over the past years. It presents resistance to usual treatments, which promotes the persistence and recurrence of genital and systemic infections.
Article
Candida vaginitis develops in approximately one-fourth of women in their childbearing years. Conventional management consists of antifungal creams or tablets/suppositories administered intravaginally. Many patients have stated preferences for oral therapy. A randomized, double-blind placebo trial compared the efficacy of a single oral 200 mg dose of fluconazole with the application of terconazole 80 mg vaginal suppository daily for 3 days. Twenty-two patients (fluconazole = 12, terconazole = 10) were evaluated during a four-month period and favorable clinical responses were observed at both early and late evaluations. Mycologic cure was attained by 75% of the fluconazole group and 50% of the terconazole group at the early evaluation. At the late evaluation, mycologic cure was 75% and 100% respectively. The mean time to onset of symptom relief was 2.4 (1.7) days for the fluconazole group and 1.8 (1.8) days for the terconazole group. The mean time to complete relief of symptoms was 6.08 (2.84) and 6.6 (2.95) days respectively. A statistically significant difference did not exist for any of these measures. Seventy-three percent of the patients preferred oral therapy.
Article
Over the past two decades, an increasing trend in the number of vaginal infections attributable to yeasts other than Candida albicans has emerged. Of these non-albicans species, C. tropicalis and C. glabrata appear to be the most important. The change in incidence pattern of yeast vaginitis can be expected to impact greatly on the treatment of this condition, because many currently used drug therapies (e.g., imidazoles) for C. albicans vaginitis do not adequately eradicate non-albicans species. A possible explanation for the recent increased selection of these species may be the shortened antifungal therapies that have been introduced during the past decade. These 1- to 3-day regimens with the older imidazoles may suppress C. albicans, but create an imbalance of flora that facilitate an overgrowth of non-albicans species. The recognition of yeast speciation and the need for use of a broad-spectrum antifungal preparation that covers these organisms is now apparent.