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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
- Publication Year :
- 2016
-
Abstract
- 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.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.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.This study focuses on very sensitive areas known to be particularly susceptible to local complications.These results suggest the usefulness of an emollient treatment for mild/moderate AD.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Administration, Topical
Anti-Inflammatory Agents
Dermatology
Placebo
Catechin
Dermatitis, Atopic
Double blind
Clinical study
030207 dermatology & venereal diseases
03 medical and health sciences
Young Adult
0302 clinical medicine
Double-Blind Method
Internal medicine
medicine
Humans
Vitamin E
Proanthocyanidins
Child
skin and connective tissue diseases
Emollients
Grape Seed Extract
business.industry
digestive, oral, and skin physiology
Ethics committee
food and beverages
Atopic dermatitis
medicine.disease
Atopic dermatiti
Treatment period
Surgery
Safety profile
Treatment Outcome
030228 respiratory system
nonsteroidal topical cream
Child, Preschool
Face
antioxidant propertie
Early adolescents
Female
business
Neck
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....f25acd5078592050ae8824ea3e585136