Low-Dose (17.5 mg/Day) Acitretin: Comparable Efficacy Without the Side Effects?

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, phototherapy, soriatane, acitretin, retinoid-related adverse events Read More

Inclusion Criteria:

• Male or female subjects 18 years of age or older.
• Surgically sterile females. Females who have had a hysterectomy or oophorectomy or completed menopause (post-menopausal for at least 1 year) are allowed. Men must agree to use 2 forms of birth control (eg condoms, spermicide).
• Stabilized on a phototherapy regimen for 4 weeks.
• Compliant with acitretin dosing at 25 mg/day and experiencing retinoid-related adverse events which, in the clinical judgement of the investigator, may benefit from a reduction in dose to 17.5 mg/day.
• Able to complete the study and to comply with the study instructions.
• Adherence to alcohol avoidance during acitretin therapy and for 2 months after discontinuation of acitretin.
• Subjects must be willing to not donate blood during the study as well as 3 years following completion of this study.
• Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.

Exclusion Criteria:

• Uncontrolled hypertriglyceridemia.
• Guttate, erythrodermic, or pustular psoriasis.
• Severely impaired hepatic function, > 3 times the upper limit of normal and the clinical investigator's judgment.
• Use of systemic immunosuppressant agents (eg. Methotrexate, cyclosporine, thioguanine, azathioprine, alefacept, egalizumab, corticosteroids) within 4 weeks of baseline and throughout the study.
• Topical vitamin A, vitamin D or analogue preparations, or anthralin within 2 weeks of study initiation.
• History of known or suspected intolerance to any of the ingredients of the investigational study product.
• Used over the counter (non-prescription) medications or herbal remedies within 2 weeks of dosing, unless agreed upon as not clinically relevant by the principal investigator.
• Participated in a previous study of the same study product.
• Currently using any medication which, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
• Currently suffering from any disease or condition which, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
• Any major illness within 30 days before screening examination.
• Considered immunocompromised.
• A clinically relevant history of or current evidence of abuse of alcohol or other drugs.
• Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
• Women of child-bearing potential (see inclusion criteria).