Determination of the Efficacy and Safety of Psirelax in the Relief of the Disease in Psoriasis
Ключови думи
Резюме
Дати
Последна проверка: | 09/30/2009 |
Първо изпратено: | 10/21/2009 |
Очаквано записване подадено: | 10/21/2009 |
Първо публикувано: | 10/22/2009 |
Изпратена последна актуализация: | 10/21/2009 |
Последна актуализация публикувана: | 10/22/2009 |
Състояние или заболяване
Интервенция / лечение
Drug: Psirelax
Фаза
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Не |
Критерии | 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. |