Low-Dose (17.5 mg/Day) Acitretin: Comparable Efficacy Without the Side Effects?
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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 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.