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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01542138
Other study ID # NIADESAH
Secondary ID
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


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
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