Prospective, randomized, double-blind, placebo-controlled, clinical trial to explore the anti-pruritic effect, the safety and local tolerability of a topical Sertaconazol cream 2% in patients with atopic dermatitis.

INTERVENTION: Trade Name: Mykosert Cream Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use CONDITION: Atopic Dermatitis Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: Main objective of the study is to explore the efficacy of a topical Sertaconazol cream 2% for prutitus in patients with atopic dermatitis in a non‐acute, stable phase in comparision to pla‐cebo. Primary end point(s): Efficacy against pruritus, measured on the itch item of the 5‐point Likert Scale in the PGA question‐naire. Secondary Objective: Safety, and tolerability of the treatment. ; Timepoint(s) of evaluation of this end point: Visit 1 (day 1), Visit 2 (day 14± 3), Visit 3 (day 28 ± 3), Visit 4 (day 42 ± 3) SECONDARY OUTCOME: Secondary end point(s): Efficacy; Intensitiy of pruritus determined by a visual analogue scale (VAS); EASI ; DLQI ; PBI ; PGA ; ; Safety and tolerability; Recording of AE, SAE, ADR; Local tolarability; Systemic tolerability:; Blood chemistry (alkaline phosphatase, bilirubin, GOT, GPT, serum creatinine); Vital signs; Timepoint(s) of evaluation of this end point: PGA:Visit 1, Visit 2, Visit 3, Visit 4; SCORAD, EASI: Visit 1, Visit 3 and Visit 4; VAS: V1, V2, V3, V4; DLQI: V1, V3, V4; PBI: V1, V3; Recording of adverse events: V2, V3, V4; Blood chemisstriy: V1, V3; Vital signs: V1, V2, V3, V4; INCLUSION CRITERIA: ‐ SCORAD (Severity SCORing of Atopic Dermatitis) =40 at inclusion ‐ Male or female (nonpregnant, nonlactating, using contra‐ception) ‐ = 18 years or = 75. ‐ Atopic lesions: Arms. Additional: Legs, Neck (areas to be evaluated: arms) ‐ Chronic pruritus, persisting for at least 6 weeks before study start ‐ At the 2 days before Visit 1 Pruritus = 7 (VAS 0‐10) ‐ At Visit 1 pruritus intensitiy = 3 (PGA questionnaire of the 5‐point Likert Scale) ‐ Signed informed consent after patient information ‐ Agreement to discontinue for the duration of the trial the use of all current moisturizers and to replace them by a standard bland moisturizer given for all patients: Excipial Hy‐drocrème ‐ Willing and able to participate in the trial as an outpatient and to comply with all trial requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects fo