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

NCT07626788 | Not Yet Recruiting DMC

• 2 other identifiers: HREC-UP-HSST 1.3/032/69MD69-10
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Plaque Psoriasis; Pentoxifylline; Add-On Therapy; Randomized Controlled Trial; Placebo-Controlled Trial

Outcome Measures

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.

  Week 12

Secondary Outcomes (3)

• Proportion of Participants Achieving PASI 75

  Week 12

• Proportion of Participants Achieving PASI 90

  Week 12

• Percent Change in PASI Score From Baseline

  Baseline to Week 12

Study Arms (2)

Pentoxifylline Add-On Therapy

ACTIVE COMPARATOR

Participants in this arm will receive pentoxifylline 400 mg orally twice daily after meals for 12 weeks, in addition to standard topical therapy for plaque psoriasis. Participants will continue their usual standard topical treatment according to clinical care. Follow-up assessments will be performed through week 16.

Drug: Pentoxifylline 400 mg Oral Tablet

Placebo Add-On Therapy

PLACEBO COMPARATOR

Participants in this arm will receive matching placebo orally twice daily after meals for 12 weeks, in addition to standard topical therapy for plaque psoriasis. Participants will continue their usual standard topical treatment according to clinical care. Follow-up assessments will be performed through week 16.

Drug: Placebo

Interventions

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.

Pentoxifylline Add-On Therapy

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.

Placebo Add-On Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wasuchon Chaichan: lead

Study Sites (1)

University of Phayao Hospital

Phayao, Changwat Phayao, 56000, Thailand

Location

Related Publications (3)

• Hassan I, Dorjay K, Anwar P. Pentoxifylline and its applications in dermatology. Indian Dermatol Online J. 2014 Oct;5(4):510-6. doi: 10.4103/2229-5178.142528.

  PMID: 25396144 BACKGROUND

• el-Mofty M, el-Darouti M, Rasheed H, Bassiouny DA, Abdel-Halim M, Zaki NS, el-Hanafy G, el-Hadidi H, Azzam O, el-Ramly A, Fawzy M. Sulfasalazine and pentoxifylline in psoriasis: a possible safe alternative. J Dermatolog Treat. 2011 Feb;22(1):31-7. doi: 10.3109/09546630903460260. Epub 2010 Jan 14.

  PMID: 20073999 BACKGROUND

• Magela Magalhaes G, Coelho da Silva Carneiro S, Peisino do Amaral K, de Freire Cassia F, Machado-Pinto J, Cuzzi T. Psoriasis and pentoxifylline: a clinical, histopathologic, and immunohistochemical evaluation. Skinmed. 2006 Nov-Dec;5(6):278-84. doi: 10.1111/j.1540-9740.2006.05681.x.

  PMID: 17085994 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Pentoxifylline; Tablets

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Wasuchon Chaichan, MD

  University of Phayao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasuchon Chaichan, MD

CONTACT

+66949749616; wasuchon.ch@gmail.com

Chonlawat Chaichan, MSc

CONTACT

wasuchon.ch@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, School of Medicine, University of Phayao

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)