Hyperpigmentation
Conditions
Keywords
Inflammatory hyperpigmentation, axillar pigmentation
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.
Interventions
DRUGDesonide
Once-a-day applying on axillar hyperpigmentation for 9 weeks
DRUGNiacinamide
Once-a-day applying on axillar hyperpigmentation for 9 weeks
DRUGPlacebo
Humectant placebo cream
Sponsors
Hospital Central Dr. Ignacio Morones Prieto
Universidad Autonoma de San Luis Potosí
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pigmentation | 9 weeks | Quantification of melanin content in histologic sections by Fontana-Masson stain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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%). |
Countries
Mexico
Outcome results
None listed