Determination of the Efficacy and Safety of Psirelax in the Relief of the Disease in Psoriasis
Sleutelwoorden
Abstract
Datums
Laatst geverifieerd: | 09/30/2009 |
Eerste ingediend: | 10/21/2009 |
Geschatte inschrijving ingediend: | 10/21/2009 |
Eerst geplaatst: | 10/22/2009 |
Laatste update ingediend: | 10/21/2009 |
Laatste update geplaatst: | 10/22/2009 |
Conditie of ziekte
Interventie / behandeling
Drug: Psirelax
Fase
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
Geslachten die in aanmerking komen voor studie | All |
Accepteert gezonde vrijwilligers | Nee |
Criteria | Inclusion Criteria: 1. Men and women between 18 and 75 years old, inclusive. 2. Clinical diagnosis of psoriasis. 3. In otherwise good general health and free of any disease or physical condition which might impair evaluation of plaque psoriasis. 4. Able to understand and willing to comply with all study requirements, particularly the regimen for administration of study drug. 5. Able to understand and willing to sign the Informed Consent Form. Exclusion Criteria: 1. 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. 2. Use of topical anti psoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within one week prior to the beginning of the study. 3. Received systemic biologic therapy to treat psoriasis (e.g., alefacept, etanercept, infliximab, efalizumab, adalimumab) within 12 weeks prior to the beginning of the study. 4. Received systemic psoriasis therapy (e.g., methotrexate, cyclosporine, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to the beginning of the study. 5. Received phototherapy (including laser), photo chemotherapy for the study areas within 4 weeks prior to the beginning of the study. 6. 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). 7. History of noncompliance to medical regimens or unwilling to comply with the study protocol. 8. Participation in an investigational drug study within 30 days prior to the beginning of the study. 9. 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. |