Atopic Dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Name: Captopril ointment
Product Code: NA
Pharmaceutical Form: Ointment
Pharmaceutical form of the placebo: Ointment
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
ACE Aps
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with chronic active atopic eczema in spots or spread symmetrical on the arms. Age 18-80 (both included) White (Caucasian) Normal weight 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Acute eczema, requiring active dermatological treatment Other skin disease (e.g. contact allergy, urticaria, psoriasis) Dermatological lighttreatment or use of solarium 4 weeks prior to the trial. Known hypersensitivity to any constituents or active ingredients in teh amounts present in the trial medication Known coronary heart disease Alcohol abuse or other type of abuse or dependency Pregnancy Participation in a clinical trial within 30 days prior to inclusion in the trial. Lack of use of safe anticonception unless the trial subject is sterile or in the postmenopause. Safe anticonception is: p-pills, Intra Uterine Device, depot injection of gestagen, subdermal implantation, hormonal vaginalring and transdermal depotplaster
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, tolerability and safety of captopril ointment (0,1 % and 0,3 %) versus placebo after dermal application once daily in 3+3 (in total 6) weeks in subjects of both sexes with chronic active atopic dermatitis.;Secondary Objective: None;Primary end point(s): Objective clinical assessment of dermatitis under use of modified EASI score, with special assessment on redness, induration/papules/oedema, dryness, excoriations and lichenisation General clinical assessment of improvement or worsening of dermatitis, Physicians Global Assessment (PGA) Subjective assessment of itching, sting/pricking/prickly sensation and pain on testareas | — |
Countries
Denmark
Outcome results
None listed