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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01149252
Recruitment Status : Terminated (Difficulties arouse in recruiting new patients)
First Posted : June 23, 2010
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Other: Psoralait Other: Placebo cream. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis.
Study Start Date : January 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Psoralait Other: Psoralait
Cream to be used as instructed.

Other: Placebo cream.
Cream to be used as instructed




Primary Outcome Measures :
  1. Psoriasis Area and Severity Index (PASI). [ Time Frame: After four weeks of treatment. ]

Secondary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI). [ Time Frame: After four weeks of treatment. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149252


Locations
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Israel
Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer
Ramat Gan, Israel
Sponsors and Collaborators
Trima, Israel Pharmaceutical Products

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Responsible Party: Trima, Israel Pharmaceutical Products
ClinicalTrials.gov Identifier: NCT01149252     History of Changes
Other Study ID Numbers: Psoriasis
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014
Keywords provided by Trima, Israel Pharmaceutical Products:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases