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

NCT ID: NCT01149252

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Psoriasis

Keywords

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Psoralait

Group Type PLACEBO_COMPARATOR

Psoralait

Intervention Type OTHER

Cream to be used as instructed.

Placebo cream.

Intervention Type OTHER

Cream to be used as instructed

Interventions

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Psoralait

Cream to be used as instructed.

Intervention Type OTHER

Placebo cream.

Cream to be used as instructed

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trima, Israel Pharmaceutical Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Psoriasis

Identifier Type: -

Identifier Source: org_study_id