Comparative, multicentre, randomised, double-blind study to assess the efficacy of tacrolimus 0.1% ointment versus fluticasone 0.005% ointment in adult patients suffering from moderate to severe atopic dermatitis and presenting with so-called "red face" lesions of the head and neck

INTERVENTION: Trade Name: Protopic 0.1% ointment Product Name: Protopic Product Code: FK506 Pharmaceutical Form: Ointment INN or Proposed INN: Tacrolimus CAS Number: 104987‐11‐3 Current Sponsor code: FK506 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.1‐ Trade Name: Cutivate 0.005% ointment Product Name: Cutivate Pharmaceutical Form: Ointment INN or Proposed INN: Fluticasone 17‐propionate CAS Number: 80474‐14‐2 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.005‐ CONDITION: Moderate to severe atopic dermatitis and presenting with so‐called "red face" lesions of the head and neck. ; MedDRA version: 7.0 Level: LLT Classification code 10003639 PRIMARY OUTCOME: Main Objective: The objective of this study is to compare the efficacy and safety of tacrolimus 0.1% ointment versus fluticasone 0.005% ointment, administered in accordance with the terms of their respective marketing authorisations, and assessed on facial lesions only. ; ; NB: the words "face" or "facial" are used to locate lesions situated on the "head, neck, chest and/or nape of neck". Primary end point(s): Efficacy will be judged from the mLEASI score (modified local Eczema Area and Severity Index, calculated solely for the "face"), assessed at week 3 (D21).; The primary endpoint of this study is the percentage of patients presenting at the week 3 visit (D21) with an improvement of at least 60% in the local mEASI score (mLEASI), by comparison with D1.; Secondary Objective: INCLUSION CRITERIA: Only patients who comply with all the criteria below may be included: ‐Male or female patients, of any racial origin. ‐Patients over the age of 16 years (after 16th birthday), presenting with moderate to severe atopic dermatitis with lesions to the head and neck defined as "red face" or "facial eczema": erythema affecting at least 10% of the surface of the "face" (head, neck, chest, nape of neck), accompanied by itching and also, in some cases, by oedema, vesicles, dryness, weeping, crusts and lichenification in a context of longstanding atopic dermatitis, accompanied or not by lesions on the body. These patients have experienced at least two flare‐ups of "facial" eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment has proved ineffective or poorly tolerated. ‐Female patients of childbearing age must, if relevant, undertake to use effective means of contraception throughout the period