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| ID | Type | Description | Link |
|---|---|---|---|
| MD69-10 | Other Grant/Funding Number | School of Medicine, University of Phayao |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Proportion of Participants Achieving PASI 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wasuchon Chaichan, MD | Contact | +66949749616 | wasuchon.ch@gmail.com | |
| Chonlawat Chaichan, MSc | Contact | wasuchon.ch@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wasuchon Chaichan, MD | University of Phayao | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Phayao Hospital | Phayao | Changwat Phayao | 56000 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25396144 | Background | 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. | |
| 20073999 | 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. |
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Individual participant data (IPD) will not be shared because the dataset contains sensitive health information and the study sample size is small, making de-identification difficult. In addition, the informed consent form does not include permission for public sharing of individual-level data.
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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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.
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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.
|
| 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. |
|
Proportion of participants who achieve at least a 90% reduction from baseline in Psoriasis Area and Severity Index (PASI) score.
| 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. | Baseline to Week 12 |
| 17085994 | 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. |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |