Low-Dose (17.5 mg/Day) Acitretin: Comparable Efficacy Without the Side Effects?
Recruitment status was Recruiting
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 of cases psoriasis is a chronically remitting and relapsing disease. Several clinical subtypes of psoriasis exist with differences in manifestations and skin areas involved.
Chronic stable plaque psoriasis (Psoriasis Vulgaris) is the commonest form of the disease, accounting for 85-90% of cases. The circumscribed infiltrated skin lesions are scaly and erythematous and often symmetrically distributed over the body. Several types of palliative therapies exist. The therapies are either topical or systemic. The severity of chronic plaque psoriasis is often determined by the percentage of body surface area (BSA) involved. For mild, moderate and severe chronic plaque psoriasis with BSA involvement of up to 20%, initial therapy is topical. Phototherapy and numerous systemic therapies are usually indicated when more than 20% of skin is affected.
Severe plaque-type psoriasis requires systemic and long-term therapy in order to induce and maintain remission. Acitretin 25mg/day combined with a phototherapy regimen is a standard treatment that provides clinically significant efficacy, however many patients experience tolerability issues due to retinoid-related adverse events. Retinoid-related adverse events include but are not limited to: alopecia, dry mucus membranes, pruritus, photosensitivity, elevation of liver enzymes, elevation of serum triglycerides, cholesterol and decrease of HDL, arthralgias, myalgias, eye irritation, blepharitis, photophobia, conjunctivitis, headaches, nausea, anemia and leukemia. Reducing the acitretin dose from 25mg/day to 17.5mg/day may provide improved tolerability without compromising efficacy.
The purpose of this study is to ascertain if reducing the acitretin dose from 25mg/day to 17.5mg/day will provide improved tolerability without compromising efficacy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Trial to Show That Subjects With Severe Plaque-Type Psoriasis Receiving Acitretin 25 mg/Day And Stabilized On A Photochemotherapy Regimen Who Are Experiencing Retinoid-Related Adverse Events, Benefit From A Reduction In Acitretin Dose to 17.5 mg/Day, While Maintaining Comparable Efficacy Along With Improved Tolerability|
- Improvement in psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Improvement and maintenance of Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), Physician's Global Assessment (PGA), and Psoriasis Disability Index and Dermatology Life Quality Index (DLQI)
- Subjective efficacy/tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Subjective efficacy/tolerability questionnaires for every subject at the end of the study
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Low dose Acitretin (17.5 mg)||
Drug: Acitretin 17.5 mg/day
lower dose of Acitretin to 17.5 mg/day from 25 mg/day in those experiencing retinoid-related side effects
Other Name: soriatane, acitretin
|Contact: Amylynne J Frankel, MD||212-241-3288||Amylynne.Frankel@mssm.edu|
|United States, New York|
|Mount Sinai Clinical Trials||Recruiting|
|New York, New York, United States, 10065|
|Contact: Giselle K Singer, MD 212-241-3288 Giselle.Singer@mssm.edu|
|Principal Investigator: Amylynne J Frankel, MD|