Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation
- Conditions
- Hyperpigmentation
- Interventions
- Registration Number
- NCT01542138
- Lead Sponsor
- Universidad Autonoma de San Luis Potosí
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 28
- Women over 18 years old
- Healthy
- Clinical diagnosis of axillar hyperpigmentation
- Pregnancy or lactation
- Obesity
- Endocrinological diseases
- Mental diseases
- Treatment for axillar hyperpigmentation in the last 2 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Niacinamide Niacinamide 4% niacinamide cream that will be randomly applied on axillar hyperpigmentation once-a-day for 9 weeks. Placebo Placebo Humectant placebo cream Desonide Desonide Once-a-day application of 0.05% desonide cream on axillar hyperpigmentation
- Primary Outcome Measures
Name Time Method Pigmentation 9 weeks Quantification of melanin content in histologic sections by Fontana-Masson stain
- Secondary Outcome Measures
Name Time Method Inflammation 9 weeks Quantification of inflammatory infiltrate in skin biopsies by histologic lymphocites infiltrate and immunohistochemistry stain anti-CD1
Trauma 9 weeks To detect trauma we measure damage in Membrane Basal by anti-collagen IV immunohistochemistry stain
Change in transepidermal water loss in hyperpigmented lesion 9 weeks Quantification of water loss measured by a evaporimeter in grams per squared meter per hour. Is an indirect measure of inflammation.
Investigator's Depigmentation Improvement 9 weeks 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%).
Trial Locations
- Locations (1)
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
🇲🇽San Luis Potosi, Mexico