Study of Efficacy of Metformin in the Treatment of Acanthosis Nigricans in Children With Obesity

Juan Pablo Castanedo-Cazares

Status and phase: Unknown; Phase 4

Conditions: Acanthosis Nigricans

Treatments: Drug: Metformin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02438020

MET-AN

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent from children and parents.
• Children younger than 18 years.
• Clinical diagnosis of acanthosis nigricans.
• Obesity.

Exclusion criteria

• Diabetes mellitus.
• Neurological diseases.
• Congenital diseases.
• Oral treatment for obesity in the last two months.
• Topical treatment for the last two months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

500 mg metformin oral intake before main meal

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo tablet before main meal.

Treatment:

Other: Placebo