Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation
Condition: Hyperpigmentation
MeSH terms: Hyperpigmentation
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Desonide; Niacinamide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once-a-day applying on axillar hyperpigmentation for 9 weeks; Once-a-day applying on axillar hyperpigmentation for 9 weeks; Humectant placebo cream
Other intervention name(s): 0.05% Desowen cream, Galderma, France.; Nicotinamide, nicomide; vanicream, cetaphil
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Desonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammatory hyperpigmentation, axillar pigmentation