Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation
NCT ID: NCT01542138
Last Updated: 2012-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
28 participants
INTERVENTIONAL
2011-07-31
2012-11-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Niacinamide
4% niacinamide cream that will be randomly applied on axillar hyperpigmentation once-a-day for 9 weeks.
Niacinamide
Once-a-day applying on axillar hyperpigmentation for 9 weeks
Desonide
Once-a-day application of 0.05% desonide cream on axillar hyperpigmentation
Desonide
Once-a-day applying on axillar hyperpigmentation for 9 weeks
Placebo
Humectant placebo cream
Placebo
Humectant placebo cream
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy
* Clinical diagnosis of axillar hyperpigmentation
Exclusion Criteria
* Obesity
* Endocrinological diseases
* Mental diseases
* Treatment for axillar hyperpigmentation in the last 2 months
18 Years
50 Years
FEMALE
Yes
Sponsors
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Hospital Central "Dr. Ignacio Morones Prieto"
OTHER
Universidad Autonoma de San Luis Potosí
OTHER
Responsible Party
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Juan Pablo Castanedo Cazares
Dermatology research director
Principal Investigators
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Bertha Torres-Alvarez, MD
Role: STUDY_CHAIR
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosi, México
Gabryela N Larraga-Piñones, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México
Juan P Castanedo-Cázares, MD
Role: STUDY_DIRECTOR
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto". San Luis Potosi, México
Locations
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Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, Mexico
Countries
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References
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Navarrete-Solis J, Castanedo-Cazares JP, Torres-Alvarez B, Oros-Ovalle C, Fuentes-Ahumada C, Gonzalez FJ, Martinez-Ramirez 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.
Torres-Alvarez B, Mesa-Garza IG, Castanedo-Cazares 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.
Other Identifiers
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NIADESAH
Identifier Type: -
Identifier Source: org_study_id