A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis
- Registration Number
- NCT02180464
- Lead Sponsor
- Almirall, S.A.
- Brief Summary
Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LAS41004 control Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily control LAS41004 Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily LAS41004 LAS41004 Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily control control Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily
- Primary Outcome Measures
Name Time Method Total symptom score day 28 vs baseline The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration
- Secondary Outcome Measures
Name Time Method Total symtom score (during study performance) Days 4, 8, 15, and 22 Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22
Physician's global assessment (PGA) Days 1, 4, 8, 15, 22 and 29 Physician's global tolerability assessment (PGTA) 4, 8, 15, 22 and 29
Trial Locations
- Locations (1)
Site 1
🇩🇪Hamburg, Germany
Site 1🇩🇪Hamburg, Germany