title: 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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: a Department of Specialized , Experimental and Diagnostic Medicine, Dermatology Unit, University of Bologna , Bologna , Italy .
authors.forename: Annalisa
authors.initials: A
authors.lastname: Patrizi
authors.affiliation: a Department of Specialized , Experimental and Diagnostic Medicine, Dermatology Unit, University of Bologna , Bologna , Italy .
authors.forename: Beatrice
authors.initials: B
authors.lastname: Raone
authors.affiliation: a Department of Specialized , Experimental and Diagnostic Medicine, Dermatology Unit, University of Bologna , Bologna , Italy .
authors.forename: Iria
authors.initials: I
authors.lastname: Neri
authors.affiliation: a Department of Specialized , Experimental and Diagnostic Medicine, Dermatology Unit, University of Bologna , Bologna , Italy .
authors.forename: Carlotta
authors.initials: C
authors.lastname: Gurioli
authors.affiliation: b Regional Office of Bari, Italian Statistical Institute , Bari , Italy , and.
authors.forename: Monica
authors.initials: M
authors.lastname: Carbonara
authors.affiliation: c Dermatology and Venereology Private Practice , Bari and Barletta , Italy.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Cassano
authors.affiliation: c Dermatology and Venereology Private Practice , Bari and Barletta , Italy.
authors.forename: Gino Antonio
authors.initials: GA
authors.lastname: Vena
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000737:chemistry / Q000627:therapeutic use*; D002392:Catechin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D004643:Emollients / Q000627:therapeutic use; D005145:Face; D005260:Female; D056604:Grape Seed Extract / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D009333:Neck; D044945:Proanthocyanidins / Q000008:administration & dosage*; D016896:Treatment Outcome; D014810:Vitamin E / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D004643:Emollients; D056604:Grape Seed Extract; C511402:Grape Seed Proanthocyanidins; D044945:Proanthocyanidins; D014810:Vitamin E; D002392:Catechin; C045651:epigallocatechin gallate
keywords: Atopic dermatitis; antioxidant properties; nonsteroidal topical cream