Status:
TERMINATED
Efficacy and Safety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic Plaque Psoriasis
Lead Sponsor:
Synvista Therapeutics, Inc
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study will be to evaluate the efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects. The secondary obj...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following criteria to qualify for entry into the study:
- Men and women between 18 and 75 years old, inclusive.
- Clinical diagnosis of stable, chronic plaque psoriasis for at least 6 months prior to Visit 1.
- In otherwise good general health and free of any disease or physical condition which might impair evaluation of plaque psoriasis.
- Plaque psoriasis treatable area \<10% BSA. (Subject palm size is equivalent to 1% of BSA.)
- Have 2 well-matched plaques (target plaques) of approximately 3 to 8 cm by 3 to 8 cm in size in areas on the right and left or front and back, at sites other than the knees, below the knees, elbows, head, face, scalp, palms, and intertriginous areas.
- A Combined Psoriasis Severity Score (CPSS) \> 6 for each target plaque at Visit 1.
- Willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
- Able to understand and willing to comply with all study requirements, particularly the regimen for administration of study drug.
- Able to understand and willing to sign the Informed Consent Form.
Exclusion
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- 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, eg, oral contraceptive agents, intrauterine device (IUD), and barrier method plus spermicide.
- Clinical diagnosis of guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
- Use of emollients or moisturizers on areas to be treated within 24 hours prior to Visits 1 or 2.
- Use of topical antipsoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to Visit 2.
- Received systemic immunomodulatory therapy to treat psoriasis (eg, methotrexate, cyclosporine, alefacept, etanercept, infliximab, efalizumab, adalimumab) within 12 weeks prior to Visit 2.
- Received phototherapy (including laser), photochemotherapy, or systemic psoriasis therapy (eg, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to Visit 2.
- 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 Visit 2.
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00782613
Start Date
November 1 2008
End Date
March 1 2009
Last Update
January 30 2009
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Ha'emek Medical Center
Afula, Israel
2
Kaplan Medical Center
Rehovot, Israel
3
Chaim Sheba Medical Center
Tel Litwinsky, Israel