Phase II Study to Investigate the Properties of Topical Twice Daily Doses of 2.5% and 5% Cis-urocanic Acid in Comparison to Active Comparator 0.1% Protopic® for up to 28 Days in Patients With Moderate or Severe Atopic Dermatitis

NCT01320579 Phase 2 COMPLETED

The purpose of this study is to evaluate dose response, safety, tolerability and efficacy of 2.5% and 5% cis-UCA in comparison to placebo and active comparator in the treatment of adult patients with moderate or severe chronic atopic dermatitis.

Details

Lead sponsor	BioCis Pharma Ltd
Phase	Phase 2
Status	COMPLETED
Enrolment	159
Start date	2011-03
Completion	2012-06

Conditions

• Atopic Dermatitis

Interventions

• Cis-UCA 2.5% emulsion cream
• Cis-UCA 5% emulsion cream
• Placebo for cis-UCA emulsion cream
• Protopic® 0.1% ointment

Primary outcomes

• Clinical Skin Assessment of erythema, oedema/papulation, oozing/crusts, excoriations, and lichenification — 37 days

Countries

Finland