Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of a new product, Psoralait, as compared to a placebo in the treatment of psoriasis.

Official Title
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Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis.

Conditions
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Psoriasis

Intervention / Treatment
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* Other: Psoralait
* Other: Placebo cream.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been clinically diagnosed as suffering from psoriasis and are or aren't scheduled for Narrow Band Ultraviolet B (UVB)phototherapy of affected areas,excluding face and genitalia. Exclusion Criteria: Women who are pregnant, lactating, planning to become pregnant, or women of child-bearing potential who have not successfully been using the same medically acceptable contraceptive methods over the previous 3 months, e.g., oral contraceptive agents, intrauterine device (IUD) and barrier method plus spermicide. Use of topical anti psoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to the beginning of the study. Received systemic biologic therapy to treat psoriasis (for example: alefacept, etanercept, infliximab, adalimumab) within 12 weeks prior to the beginning of the study. Received systemic psoriasis therapy (for example: methotrexate, cyclosporine, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to the beginning of the study. Received phototherapy (including laser), photo chemotherapy or climatotherapy within 4 weeks prior to the beginning of the study. Recent history (within past 12 months) of alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1.5 oz distilled spirits). History of noncompliance to medical regimens or unwilling to comply with the study protocol. Participation in an investigational drug study within 30 days prior to the beginning of the study. Serious or unstable medical or psychological conditions that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Psoralait<br> | Other: Psoralait<br>* Cream to be used as instructed.<br>Other: Placebo cream.<br>* Cream to be used as instructed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI). |  | After four weeks of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index (DLQI). |  | After four weeks of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis