Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation

Study Overview
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Brief Summary
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Axillary hyperpigmentation is a frequent consultation in dark skin populations although its exact prevalency is unknown. Currently, there are not studies about physiopathology and treatment for this entity. The objective is to evaluate the depigmenting effect of topical 4% niacinamide versus 0.05% desonide in axillary hyperpigmentation. At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50 years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. No hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9 weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.

Detailed Description
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Axillary hyperpigmentation is frequent in dark skin population, is possible a type of postinflammatory hyperpigmentation present in phototypes IV to VI. Previous reports have described increased intensity of Masson-Fontana, anti-tyrosinase and/or anti-TRP1 staining, indicative of melanocyte stimulation and increased melanin production, but the exact mechanism is unknown. The hair plucking, the rubbing of clothes on skin and physical stimulation from washing and drying the underarm are factors implicated. The objective of our study is evaluate the depigmenting effect of topical niacinamide versus desonide in axillary hyperpigmentation through the histochemistry and immunohistochemistry staining. The study population will include at least 30 axillas with hyperpigmentation in a population with phototype III-V and aged 18-50 years old. Informed consent will be obtained from the patients, under approval by the local ethical committee (Institutional Review Board). The patients are going to be randomly assigned to receive 4% niacinamide, 0.05% desonide or placebo daily once at night. None hygienic habit is going to be modified. Volunteers will be evaluated at baseline and 9 weeks later, with histochemical and immunohistochemical analysis (biopsies), colorimetric value axis L*, a*, b* (Chromameter CR-300, Minolta, Osaka, Japan), Transepidermal Water Loss (TEWL) by means of an evaporimeter (Dermalab, Cortex Technology, Denmark), clinical assessment and photography control. Statistical analysis was performed using t student, the level of significance was set at 5%. And clinical evaluation will be analysed by means of chi square test.

Official Title
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A Double Blind, Randomized Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation

Conditions
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Hyperpigmentation

Intervention / Treatment
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* Drug: Desonide
* Drug: Niacinamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over 18 years old Healthy Clinical diagnosis of axillar hyperpigmentation Exclusion Criteria: Pregnancy or lactation Obesity Endocrinological diseases Mental diseases Treatment for axillar hyperpigmentation in the last 2 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Niacinamide<br>4% niacinamide cream that will be randomly applied on axillar hyperpigmentation once-a-day for 9 weeks. | Drug: Niacinamide<br>* Once-a-day applying on axillar hyperpigmentation for 9 weeks<br>* Other names: Nicotinamide, nicomide;|
| Active Comparator: Desonide<br>Once-a-day application of 0.05% desonide cream on axillar hyperpigmentation | Drug: Desonide<br>* Once-a-day applying on axillar hyperpigmentation for 9 weeks<br>* Other names: 0.05% Desowen cream, Galderma, France.;|
| Placebo Comparator: Placebo<br>Humectant placebo cream | Drug: Placebo<br>* Humectant placebo cream<br>* Other names: vanicream, cetaphil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pigmentation | Quantification of melanin content in histologic sections by Fontana-Masson stain | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Quantification of inflammatory infiltrate in skin biopsies by histologic lymphocites infiltrate and immunohistochemistry stain anti-CD1 | 9 weeks | 
| Trauma | To detect trauma we measure damage in Membrane Basal by anti-collagen IV immunohistochemistry stain | 9 weeks | 
| Change in transepidermal water loss in hyperpigmented lesion | Quantification of water loss measured by a evaporimeter in grams per squared meter per hour. Is an indirect measure of inflammation. | 9 weeks | 
| Investigator's Depigmentation Improvement | Clinical improvement is assessed by means of digital photographic registration (frontal, right, and left views). Two independent observers clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%). | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory hyperpigmentation, axillar pigmentation