A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis

Study Overview
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Brief Summary
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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).

Official Title
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A Phase IIa, 28-day Treatment, Multi-center, Randomized, Comparator-controlled, Observer-blind Trial With Intra-individual Left/Right Comparison to Investigate the Anti-psoriatic Efficacy and the Safety of an LAS41004 Formulation in Comparison to an Active Reference in Patients With Mild to Moderate Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: LAS41004
* Drug: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (main): mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6; female volunteers of childbearing potential* must agree to use appropriate and reliable methods of contraception written informed consent obtained. Exclusion Criteria (main): severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial; treatment with any systemic medications which might counter or influence the trial aim or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial; treatment with vitamin A supplements; treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months; treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial; known allergic reactions, irritations or hypersensitivity to the active ingredients contraindications according to summary of product characteristics (SmPC) of the active comparator: - pregnancy or nursing;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAS41004<br>Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily | Drug: LAS41004<br> <br> Drug: control<br> <br> |
| Active Comparator: control<br>Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily | Drug: LAS41004<br> <br> Drug: control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total symptom score | The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration | day 28 vs baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total symtom score (during study performance) | Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, topical