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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

Tracking Information
First Submitted Date  ICMJE June 20, 2010
First Posted Date  ICMJE June 23, 2010
Last Update Posted Date December 17, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2010)
Psoriasis Area and Severity Index (PASI). [ Time Frame: After four weeks of treatment. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01149252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2010)
Dermatology Life Quality Index (DLQI). [ Time Frame: After four weeks of treatment. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis
Official Title  ICMJE Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Other: Psoralait
    Cream to be used as instructed.
  • Other: Placebo cream.
    Cream to be used as instructed
Study Arms  ICMJE Placebo Comparator: Psoralait
Interventions:
  • Other: Psoralait
  • Other: Placebo cream.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 16, 2014)
15
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2010)
180
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01149252
Other Study ID Numbers  ICMJE Psoriasis
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trima, Israel Pharmaceutical Products
Study Sponsor  ICMJE Trima, Israel Pharmaceutical Products
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Trima, Israel Pharmaceutical Products
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP