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

NCT01542138 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-11-29

No results posted yet for this study

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.

Conditions

  • Hyperpigmentation

Interventions

DRUG

Desonide

Once-a-day applying on axillar hyperpigmentation for 9 weeks

DRUG

Niacinamide

Once-a-day applying on axillar hyperpigmentation for 9 weeks

DRUG

Placebo

Humectant placebo cream

Sponsors & Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

    collaborator OTHER

  • Universidad Autonoma de San Luis Potosí

    lead OTHER

Principal Investigators

  • Bertha Torres-Alvarez, MD · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosi, México

  • Gabryela N Larraga-Piñones, MD · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México

  • Juan P Castanedo-Cázares, MD · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542138 on ClinicalTrials.gov