Psoriasis
Conditions
Keywords
Plaque Psoriasis, Pentoxifylline, Add-On Therapy, Randomized Controlled Trial, Placebo-Controlled Trial
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Wasuchon Chaichan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants, investigators, care providers, and outcome assessors will be masked to treatment assignment. Pentoxifylline and placebo will be prepared in identical capsules and dispensed using coded study drug packages. The allocation code will be kept confidential and will not be revealed until completion of the study, unless unblinding is required for participant safety.
Intervention model description
This is a two-arm, parallel-group, randomized, double-blind, placebo-controlled trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either pentoxifylline add-on therapy or placebo add-on therapy while continuing standard topical treatment. The treatment period will be 12 weeks, followed by follow-up until week 16.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 65 years. * Clinical diagnosis of mild-to-moderate plaque psoriasis, defined as Psoriasis Area and Severity Index (PASI) score 3 to 10 or body surface area (BSA) involvement 3% to 10%, as assessed by a physician. * Receiving stable standard topical therapy for at least 2 weeks before enrollment. * Able and willing to provide written informed consent. * Willing to comply with the study protocol and scheduled follow-up visits.
Exclusion criteria
* Use of biologic agents within 12 weeks before enrollment. * Psoriatic arthritis requiring systemic therapy. * Pregnant or breastfeeding. * Severe liver disease or severe kidney disease. * History of significant bleeding disorder or current use of anticoagulant therapy that cannot be appropriately managed. * Known hypersensitivity to pentoxifylline or related xanthine derivatives. * Any serious medical condition or safety concern that, in the investigator's judgment, makes participation inappropriate. * Refusal or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving PASI 50 | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving PASI 75 | Week 12 | Proportion of participants who achieve at least a 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score. |
| Proportion of Participants Achieving PASI 90 | Week 12 | Proportion of participants who achieve at least a 90% reduction from baseline in Psoriasis Area and Severity Index (PASI) score. |
| Percent Change in PASI Score From Baseline | Baseline to Week 12 | 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. |
Countries
Thailand
Contacts
CONTACTWasuchon Chaichan, MD
CONTACTChonlawat Chaichan, MSc
PRINCIPAL_INVESTIGATORWasuchon Chaichan, MD
University of Phayao
Outcome results
None listed