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Pentoxifylline Add-On Therapy for Mild-to-Moderate Plaque Psoriasis

ConditionPsoriasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWasuchon Chaichan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Use of biologic agents within 12 weeks before enrollment.

Psoriatic arthritis requiring systemic therapy.

Pregnant or breastfeeding.

Severe liver disease or severe kidney disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pentoxifylline 400 mg Oral Tablet

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Pentoxifylline Add-On TherapyActive comparator 1 intervention
Group B: Placebo Add-On TherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wasuchon Chaichan

Lead sponsor

University of Phayao

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: