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

Phase 4

Terminated

• Conditions: Psoriasis
• Interventions: Other: Psoralait; Other: Placebo cream.

• Registration Number: NCT01149252
• Lead Sponsor: Trima, Israel Pharmaceutical Products

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-20
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Study Start: 2011-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psoralait	Placebo cream.	-
Psoralait	Psoralait	-

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI).	After four weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI).	After four weeks of treatment.

Trial Locations

Locations (1)

Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer; 🇮🇱 Ramat Gan, Israel