Randomized, controlled, double-blind clinical study evaluating the safety and efficacy of MD2011001 cream in mild-to-moderate atopic dermatitis of the face and neck in children, adolescents and adults

J Dermatolog Treat. 2016 Aug;27(4):346-50. doi: 10.3109/09546634.2015.1115814. Epub 2015 Dec 10.

Abstract

Introduction: This mono-center randomized, controlled, double-blind study evaluates the safety and efficacy of MD2011001 cream versus placebo, in mild-to-moderate atopic dermatitis (AD). MD2011001 is a nonsteroidal topical cream containing vitamin E, epigallocatechin gallate and grape seed procyanidins.

Methods: Patients with AD (corresponding to an IGA score of 2 or 3), involving the face, the perioral/periocular area and/or the neck, were enrolled. Patients were randomized 1:1 ratio to receive MD2011001 or placebo before the start of the study (D0), then evaluated after 7 days, and after 28 days. The study was approved by the Local Independent Ethics Committee and conducted according to the Declaration of Helsinki and local regulations. The statistical tests used were the Wilcoxon test and the Mann-Whitney U-test.

Results: Forty-four patients (29F and 15M) were enrolled. The IGA values showed a statistically significant reduction during the treatment period obtaining a favorable safety profile and local tolerance for both the products. The reduction in the surface area affected by AD was significantly faster with MD2011001.

Discussion: This study focuses on very sensitive areas known to be particularly susceptible to local complications.

Conclusions: These results suggest the usefulness of an emollient treatment for mild/moderate AD.

Keywords: Atopic dermatitis; antioxidant properties; nonsteroidal topical cream.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents / chemistry
  • Anti-Inflammatory Agents / therapeutic use*
  • Catechin / administration & dosage
  • Catechin / analogs & derivatives*
  • Child
  • Child, Preschool
  • Dermatitis, Atopic / drug therapy*
  • Double-Blind Method
  • Emollients / therapeutic use
  • Face
  • Female
  • Grape Seed Extract / administration & dosage*
  • Humans
  • Male
  • Neck
  • Proanthocyanidins / administration & dosage*
  • Treatment Outcome
  • Vitamin E / administration & dosage*
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Emollients
  • Grape Seed Extract
  • Grape Seed Proanthocyanidins
  • Proanthocyanidins
  • Vitamin E
  • Catechin
  • epigallocatechin gallate