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

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

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.

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Other: Psoralait; Other: Placebo cream.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Psoralait	Other: Psoralait; Cream to be used as instructed.; Other: Placebo cream.; Cream to be used as instructed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Trima, Israel Pharmaceutical Products

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 20, 2010
• First Submitted That Met QC Criteria: June 22, 2010
• First Posted (Estimate): June 23, 2010

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: Psoriasis