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

This study has been completed.
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT01542138
First received: February 21, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Hyperpigmentation
Drug: Desonide
Drug: Niacinamide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Pigmentation [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Quantification of melanin content in histologic sections by Fontana-Masson stain


Secondary Outcome Measures:
  • Inflammation [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Quantification of inflammatory infiltrate in skin biopsies by histologic lymphocites infiltrate and immunohistochemistry stain anti-CD1

  • Trauma [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    To detect trauma we measure damage in Membrane Basal by anti-collagen IV immunohistochemistry stain

  • Change in transepidermal water loss in hyperpigmented lesion [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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%).


Enrollment: 28
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 0.05% Desowen cream, Galderma, France.
Placebo Comparator: Placebo
Humectant placebo cream
Drug: Placebo
Humectant placebo cream
Other Name: vanicream, cetaphil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542138

Locations
Mexico
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78210
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
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
  More Information

Publications:
Responsible Party: Juan Pablo Castanedo Cazares, Dermatology research director, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT01542138     History of Changes
Other Study ID Numbers: NIADESAH
Study First Received: February 21, 2012
Last Updated: November 27, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Universidad Autonoma de San Luis Potosí:
Inflammatory hyperpigmentation, axillar pigmentation

Additional relevant MeSH terms:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Desonide
Niacin
Niacinamide
Nicotinic Acids
Anti-Inflammatory Agents
Antimetabolites
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014