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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01149252
• Other study ID #: Psoriasis
• Status: Terminated
• Phase: Phase 4
• First received: June 20, 2010
• Last updated: December 16, 2014
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: Trima, Israel Pharmaceutical Products
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• Psoralait
Cream to be used as instructed.
• Placebo cream.
Cream to be used as instructed

Locations

Country	Name	City	State
Israel	Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Trima, Israel Pharmaceutical Products

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index (PASI).		After four weeks of treatment.	No
Secondary	Dermatology Life Quality Index (DLQI).		After four weeks of treatment.	No