Efficacy and tolerability of captopril oinment 0,1% og 0,3% in atopic dermatitis. A randomised, double-blind, placebocontrolled, doseescalating, intra-individual clinical study.

Conditions: Atopic Dermatitis
MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitis

Registration Number: EUCTR2008-004432-20-DK

Lead Sponsor: ACE Aps

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>General clinical assessment of improvement or worsening of dermatitis, Physicians Global Assessment (PGA)<br>Subjective assessment of itching, sting/pricking/prickly sensation and pain on testareas<br><br>

Secondary Outcome Measures