Evaluation of the efficacy of a topical formulation containing ASF-1075 in the treatment of chronic hand dermatitis

INTERVENTION: Product Name: ASF‐1075 Pharmaceutical Form: Cream Current Sponsor code: ASF‐1075 Concentration unit: % percent Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Topical use (Noncurrent) CONDITION: male or female patients with chronic hand dermatitis, aged 18 to 70 years PRIMARY OUTCOME: Main Objective: To compare the efficacy of a topical ASF‐1075 formulation and the corresponding active ingredient‐free vehicle in the treatment of chronic hand dermatitis Primary end point(s): The primary endpoint is the clinical assessment of skin condition using the HECSI (hand eczema severity index); ; Secondary Objective: INCLUSION CRITERIA: • men and women aged 18 to 70 years; • patients suffering from chronic hand dermatitis rated mild to moderate according to Investigator’s global assessment and which has persisted for more than 6 month in spite of attempts to identify and remove cause; • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide; • written informed consent obtained. 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 for this age range