Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01542138
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : November 29, 2012
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí

Tracking Information
First Submitted Date  ICMJE February 21, 2012
First Posted Date  ICMJE March 2, 2012
Last Update Posted Date November 29, 2012
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2012)
Pigmentation [ Time Frame: 9 weeks ]
Quantification of melanin content in histologic sections by Fontana-Masson stain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2012)
  • Inflammation [ Time Frame: 9 weeks ]
    Quantification of inflammatory infiltrate in skin biopsies by histologic lymphocites infiltrate and immunohistochemistry stain anti-CD1
  • Trauma [ Time Frame: 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 [ 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.
  • 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%).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation
Official Title  ICMJE A Double Blind, Randomized Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperpigmentation
Intervention  ICMJE
  • Drug: Desonide
    Once-a-day applying on axillar hyperpigmentation for 9 weeks
    Other Name: 0.05% Desowen cream, Galderma, France.
  • Drug: Niacinamide
    Once-a-day applying on axillar hyperpigmentation for 9 weeks
    Other Name: Nicotinamide, nicomide
  • Drug: Placebo
    Humectant placebo cream
    Other Name: vanicream, cetaphil
Study Arms  ICMJE
  • Active Comparator: Niacinamide
    4% niacinamide cream that will be randomly applied on axillar hyperpigmentation once-a-day for 9 weeks.
    Intervention: Drug: Niacinamide
  • Active Comparator: Desonide
    Once-a-day application of 0.05% desonide cream on axillar hyperpigmentation
    Intervention: Drug: Desonide
  • Placebo Comparator: Placebo
    Humectant placebo cream
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2012)
28
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2012)
25
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01542138
Other Study ID Numbers  ICMJE NIADESAH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí
Study Sponsor  ICMJE Universidad Autonoma de San Luis Potosí
Collaborators  ICMJE Hospital Central "Dr. Ignacio Morones Prieto"
Investigators  ICMJE
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
PRS Account Universidad Autonoma de San Luis Potosí
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP