A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
Phase 1
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Glaxal Base cream vehicle
- Registration Number
- NCT02376049
- Lead Sponsor
- LEO Pharma
- Brief Summary
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.
- Detailed Description
Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Subject with mild to moderate AD
- Four comparable TAs
- TSS of at least 5 on all TAs
- Difference in TSS not greater than 2 between the TAs
- Sign score erythema ≥ 2 between the TAs
- TAs should be at least 2 cm apart
Exclusion Criteria
- Investigator's opinion
- Fitzpatrick skin type >5
- Topical (i.e. on the TAs) treatment with prohibited medications
- Systemic treatment with prohibited medications
- Phototherapy within prohibited timeframe
- Use of emollients within prohibited timeframe
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pimecrolimus cream Pimecrolimus cream Pimecrolimus 1% cream once daily for 14 days Betamethasone dipropionate cream Betamethasone dipropionate cream Betamethasone dipropionate 0.05% cream once daily for 14 days Clobetasol propionate cream Clobetasol propionate cream Clobetasol propionate 0.05% cream once daily for 14 days Glaxal Base cream vehicle Glaxal Base cream vehicle Glaxal Base cream vehicle once daily for 14 days
- Primary Outcome Measures
Name Time Method Total Sign Score (TSS) change 14 days TSS change at end of treatment in relation to baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
Beit Harofim
🇮🇱Netanya, Israel