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

Hyperpigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542138
• Other study ID #: NIADESAH
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2012
• Last updated: November 27, 2012
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperpigmentation

Intervention

Drug:
• Desonide
Once-a-day applying on axillar hyperpigmentation for 9 weeks
• Niacinamide
Once-a-day applying on axillar hyperpigmentation for 9 weeks
• Placebo
Humectant placebo cream

Locations

Country	Name	City	State
Mexico	Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí	Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Navarrete-Solís J, Castanedo-Cázares JP, Torres-Álvarez B, Oros-Ovalle C, Fuentes-Ahumada C, González FJ, Martínez-Ramírez JD, Moncada B. A Double-Blind, Randomized Clinical Trial of Niacinamide 4% versus Hydroquinone 4% in the Treatment of Melasma. Dermatol Res Pract. 2011;2011:379173. doi: 10.1155/2011/379173. Epub 2011 Jul 21. — View Citation

Torres-Álvarez B, Mesa-Garza IG, Castanedo-Cázares JP, Fuentes-Ahumada C, Oros-Ovalle C, Navarrete-Solis J, Moncada B. Histochemical and immunohistochemical study in melasma: evidence of damage in the basal membrane. Am J Dermatopathol. 2011 May;33(3):291-5. doi: 10.1097/DAD.0b013e3181ef2d45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pigmentation	Quantification of melanin content in histologic sections by Fontana-Masson stain	9 weeks	No
Secondary	Inflammation	Quantification of inflammatory infiltrate in skin biopsies by histologic lymphocites infiltrate and immunohistochemistry stain anti-CD1	9 weeks	No
Secondary	Trauma	To detect trauma we measure damage in Membrane Basal by anti-collagen IV immunohistochemistry stain	9 weeks	No
Secondary	Change in transepidermal water loss in hyperpigmented lesion	Quantification of water loss measured by a evaporimeter in grams per squared meter per hour. Is an indirect measure of inflammation.	9 weeks	No
Secondary	Investigator's Depigmentation Improvement	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	No