Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo on change from baseline in Total Lesion Symptom Score in subjects with mild to moderate atopic dermatitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aquinox Pharmaceuticals (Canada) Inc.
• Collaborator: Innovaderm Research Inc.

Criteria

Inclusion Criteria:

1. Male or female aged from 18 to 65 years old

2. Confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria

3. At least a 6 months history of atopic dermatitis.

4. Body Surface Area (BSA) covered with atopic dermatitis of 1% or more

5. Mild or moderate atopic dermatitis (IGA score of 2 or 3).

6. TLSS of 5 or more at Day 0.

7. Subject must use a non-medicated emollient daily for at least (≥) 7 days prior to Day 0 and should continue using that same emollient, at the same frequency, throughout the study.

Exclusion Criteria:

1. Female subject who is pregnant or breast-feeding

2. Unstable or clinically infected atopic dermatitis