Acanthosis Nigricans Clinical Trial
Official title:
Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity
Obesity is often accompanied by insulin resistance and/or hyperinsulinemia. Acanthosis
nigricans (AN) is a skin condition commonly present on the neck of obese children. Metformin
is a useful drug for conditions characterized by insulin resistance.The aim of this study is
to compare the efficacy of metformin versus placebo on AN lesions of the neck as well as
their effects on metabolic and anthropometric variables in a sample of obese children. This
is a 12-week randomized, double-blind randomized trial involving obese children with AN to
receive either metformin or placebo.
Evaluations will be performed every three weeks. Clinical, histological and colorimetric
assessments of AN lesions will be compared initially and at the conclusion of the study.
Acanthosis nigricans (AN) are lesions affecting localized areas of the skin in persons with
obesity and/or hyperinsulinemia. Roughening of the skin is related with histological
papillomatosis and the skin darkening is due to hyperkeratosis. Biochemical mechanisms for
developing this hyperplastic lesion involve local cutaneous growth factors. Nearly 40% of
Native American teenagers have acanthosis nigricans, whereas about 13% of African American,
6% of Hispanic, and less than 1% of white, non-Hispanic children aged 10-19 have clinically
apparent acanthosis nigricans. AN is a clinical surrogate of laboratory-documented
hyperinsulinemia.
The aim of this study is to compare the efficacy of metformin versus placebo on AN lesions
of the neck as well as their effects on metabolic (HOMA, triglycerides, cholesterol) and
anthropometric variables (BMI, waist) in a sample of obese children. This is a 12-week
randomized, double-blind randomized trial involving obese children with AN to receive either
metformin or placebo.
Evaluations will be performed every three weeks. Clinical, histological and colorimetric
assessments of AN lesions will be compared initially and at the conclusion of the study.
Burke´s scale, papillomatosis and hyperkeratosis, and the L* axis of will be used to measure
the AN improvement.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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