Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis
Primary Purpose
Psoriasis
Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Psoralait
Placebo cream.
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis
Eligibility 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.
Sites / Locations
- Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
Psoralait
Arm Description
Outcomes
Primary Outcome Measures
Psoriasis Area and Severity Index (PASI).
Secondary Outcome Measures
Dermatology Life Quality Index (DLQI).
Full Information
NCT ID
NCT01149252
First Posted
June 20, 2010
Last Updated
December 16, 2014
Sponsor
Trima, Israel Pharmaceutical Products
1. Study Identification
Unique Protocol Identification Number
NCT01149252
Brief Title
Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis
Official Title
Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Difficulties arouse in recruiting new patients
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trima, Israel Pharmaceutical Products
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psoralait
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Psoralait
Intervention Description
Cream to be used as instructed.
Intervention Type
Other
Intervention Name(s)
Placebo cream.
Intervention Description
Cream to be used as instructed
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI).
Time Frame
After four weeks of treatment.
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI).
Time Frame
After four weeks of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Phototherapy and Dermatology Day Care Center, Sheba Medical Center, Tel Hashomer
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis
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