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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | October 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 17 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Central Dr.Ignacio Morones Prieto | San Luis Potosi | SLP |
Lead Sponsor | Collaborator |
---|---|
Juan Pablo Castanedo-Cazares | Hospital Central "Dr. Ignacio Morones Prieto" |
Mexico,
Bellot-Rojas P, Posadas-Sanchez R, Caracas-Portilla N, Zamora-Gonzalez J, Cardoso-Saldaña G, Jurado-Santacruz F, Posadas-Romero C. Comparison of metformin versus rosiglitazone in patients with Acanthosis nigricans: a pilot study. J Drugs Dermatol. 2006 Oct;5(9):884-9. — View Citation
Freemark M, Bursey D. The effects of metformin on body mass index and glucose tolerance in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes. Pediatrics. 2001 Apr;107(4):E55. — View Citation
Romo A, Benavides S. Treatment options in insulin resistance obesity-related acanthosis nigricans. Ann Pharmacother. 2008 Jul;42(7):1090-4. doi: 10.1345/aph.1K446. Epub 2008 May 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum fasting insulin | Quantification of serum fasting insulin in pmol/L or mIU/L, at baseline and at the end of the study. | baseline and 12 weeks | No |
Other | Serum fasting glucose | Quantification of serum fasting glucose in mg/dL. | baseline and 12 weeks | No |
Other | Serum fasting lipids | Quantification of serum fasting lipids in mg/dL. Cholesterol (HDL, LDL, VLDL) and triglycerides. | baseline and 12 weeks | No |
Other | Waist measurement | Waist measurement in centimeters. | baseline and 12 weeks | No |
Other | Quantification of Body mass index (BMI) | BMI It is the measure of body fat based on height and weight. The BMI is the body mass divided by the square of the body height, and expressed in units of kg/m2, resulting from weight in kilograms and height in metres | baseline and 12 weeks | No |
Primary | Clinical improvement of acanthosis nigricans | Initial and after intervention assessment of acanthosis nigricans using the quantitative scale of Burke (Diabetes Care 22:1655-1659, 1999). Five anatomical sites were chosen to assess the presence and extent of AN: neck, axilla, knuckles, elbows, and knees. The neck and axilla are graded for severity on a scale from 0 to 4. For AN present on the neck, texture of the affected area is also measured on a scale from 0 to 3. Knuckles, elbows, and knees are graded as AN present (1) or absent (0). Score goes from 0 to 14. |
baseline and 12 weeks | No |
Secondary | Histological improvement of acanthosis nigricans | Epidermal and stratum corneum thickness of 3 mm skin samples obtained from neck will be measured using an image processing software initially and at the end of trial. | baseline and 12 weeks | No |
Secondary | Depigmentation of acanthosis nigricans | Quantification of pigmentation change of lesions by means of the L axis of the CIE system. 0 is pure white, 100 y total dark. Initially, and at the end of study. | baseline and 12 weeks | No |
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