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

November 27, 2012 updated by: Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosi, Mexico, 78210
        • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation
Time Frame: 9 weeks
Quantification of inflammatory infiltrate in skin biopsies by histologic lymphocites infiltrate and immunohistochemistry stain anti-CD1
9 weeks
Trauma
Time Frame: 9 weeks
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
Time Frame: 9 weeks
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
Time Frame: 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%).
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Collaborators

Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

  • Study Chair: Bertha Torres-Alvarez, MD, Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosi, México
  • Principal Investigator: Gabryela N Larraga-Piñones, MD, Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México
  • Study Director: Juan P Castanedo-Cázares, MD, Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

November 29, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIADESAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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