Status:
UNKNOWN
Low-Dose (17.5 mg/Day) Acitretin: Comparable Efficacy Without the Side Effects?
Lead Sponsor:
Frankel, Amylynne, M.D.
Collaborating Sponsors:
Stiefel, a GSK Company
Conditions:
Psoriasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Psoriasis is a chronic skin disorder with a prevalence of approximately 1-3% worldwide. At present, there is no curative therapy available and the clinical course is unpredictable, but in the majority...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01228409
Start Date
October 1 2010
Last Update
June 22 2011
Active Locations (1)
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1
Mount Sinai Clinical Trials
New York, New York, United States, 10065