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

NCT01149252 | Terminated Phase 4 DMC

• 1 other identifier: Psoriasis
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI).

  After four weeks of treatment.

Secondary Outcomes (1)

• Dermatology Life Quality Index (DLQI).

  After four weeks of treatment.

Study Arms (1)

Psoralait

PLACEBO COMPARATOR

Other: Psoralait; Other: Placebo cream.

Interventions

Psoralait OTHER

Cream to be used as instructed.

Psoralait

Placebo cream. OTHER

Cream to be used as instructed

Psoralait

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trima, Israel Pharmaceutical Products: lead

Study Sites (1)

Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2010
• First Posted: June 23, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

IL (1)