This study will evaluate whether pentoxifylline, when used as an add-on treatment to standard topical therapy, is effective and safe for adults with mild-to-moderate plaque psoriasis. Participants will be randomly assigned to receive either pentoxifylline or placebo twice daily for 12 weeks, while continuing their standard topical treatment. The study will compare improvement in psoriasis severity, itch, physician assessment, quality of life, and adverse events between the two groups. Participants will be followed for a total of 16 weeks.
Psoriasis is a chronic inflammatory skin disease that may cause persistent plaques, itching, and impaired quality of life. Many patients with mild-to-moderate plaque psoriasis are treated mainly with topical therapy, but some patients have an inadequate response or ongoing symptoms. Pentoxifylline is an oral methylxanthine derivative with anti-inflammatory and microcirculatory effects, including inhibition of pro-inflammatory cytokines such as TNF-alpha, IL-1, and IL-6. These mechanisms may be relevant to the inflammatory pathways involved in psoriasis. This study is a prospective, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate pentoxifylline as an add-on therapy to standard topical treatment in adults with mild-to-moderate plaque psoriasis. Eligible participants will be randomly assigned in a 1:1 ratio to receive either pentoxifylline add-on therapy or placebo add-on therapy. All participants will continue standard topical treatment according to usual clinical care. The treatment period will be 12 weeks, followed by an additional follow-up period until week 16. Clinical assessments will be performed at baseline and follow-up visits to evaluate psoriasis severity, body surface area involvement, physician global assessment, itch severity, quality of life, and safety. The primary objective is to compare the proportion of participants achieving PASI 50 at week 12 between the pentoxifylline and placebo groups. Safety will be assessed by monitoring adverse events, serious adverse events, and laboratory parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Pentoxifylline 400 mg capsule will be taken orally twice daily after meals, once in the morning and once in the evening, for 12 weeks. The intervention will be given as add-on therapy while participants continue standard topical treatment for plaque psoriasis.
Matching placebo capsule will be taken orally twice daily after meals, once in the morning and once in the evening, for 12 weeks. The placebo will be given as add-on therapy while participants continue standard topical treatment for plaque psoriasis.
University of Phayao Hospital
Phayao, Changwat Phayao, Thailand
Proportion of Participants Achieving PASI 50
Proportion of participants who achieve at least a 50% reduction from baseline in Psoriasis Area and Severity Index (PASI) score. PASI is a physician-assessed measure of psoriasis severity based on erythema, induration, scaling, and affected body surface area.
Time frame: Week 12
Proportion of Participants Achieving PASI 75
Proportion of participants who achieve at least a 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score.
Time frame: Week 12
Proportion of Participants Achieving PASI 90
Proportion of participants who achieve at least a 90% reduction from baseline in Psoriasis Area and Severity Index (PASI) score.
Time frame: Week 12
Percent Change in PASI Score From Baseline
Percent change from baseline in Psoriasis Area and Severity Index (PASI) score. PASI is assessed by a physician based on erythema, induration, scaling, and affected body surface area.
Time frame: Baseline to Week 12
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