Double-blind, placebo-controlled study to investigate the efficacy and safety of IDEA-070 (ketoprofen in Transfersome®) in different dermatological diseases

INTERVENTION: Product Name: IDEA‐070 Product Code: IDEA‐070/41 Pharmaceutical Form: Cutaneous suspension INN or Proposed INN: Ketoprofenum CAS Number: 22071‐15‐4 Current Sponsor code: IDEA‐070/41 Concentration unit: % percent Concentration type: equal Concentration number: 2,4‐ Pharmaceutical form of the placebo: Cutaneous suspension Route of administration of the placebo: Cutaneous use CONDITION: Patients with different dermatological diseases ? Atopic eczema (MedDRA 6.0, LLT: 10003641) ? Dishydrotic hand eczema (MedDRA 6.0, LLT: 10013913) ? Plaque type psoriasis (MedDRA 6.0, LLT: 10050576) ? Seborrheic eczema (MedDRA 6.0, LLT: 10039795) ? Acne vulgaris (MedDRA 6.0, LLT: 10000519) ; MedDRA version: 6.0 Level: LLT Classification code 10040833 PRIMARY OUTCOME: Main Objective: Clinical evaluation of the efficacy of IDEA‐070 (ketoprofen in Transfersome®) in patients with different dermatological diseases using the Investigator Global Assessment score (IGA).; Primary end point(s): The primary endpoint will be the investigator global assessment using the Investigator Global Assessment SCORE (IGA); Secondary Objective: 1.Clinical evaluation of the efficacy of IDEA‐070 (ketoprofen in Transfersome®) in patients with different dermatological diseases using the following scores:; a) Patient Global Assessment score (PGA); b) Indication specific scores (SCORAD, DASI, PASI, GAGS) ; ; 2.Safety of IDEA‐070 evaluated by; a) description of AE profile; b) changes in laboratory values; c) physical examination; d) vital signs including body weight and body temperature; e) ketoprofen plasma levels; INCLUSION CRITERIA: One of the following dermal indications (mild to moderate): ? Atopic eczema in the crook of the arm or hollow of the knee ? Dishydrotic hand eczema ? Plaque type psoriasis (hyperkeratoses removed before treatment by urea or salicylic acid) ? Seborrheic eczema ? Acne vulgaris Aged 18–80 years Reliable method of contraception for women of childbearing potential Are the trial subjects under 18? 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range