Pentoxifylline Add-On Therapy for Mild-to-Moderate Plaque Psoriasis (PTX-PSO)
Efficacy and Safety of Pentoxifylline as Add-On Therapy for Mild-to-Moderate Plaque Psoriasis: A Double-Blind Randomized Placebo-Controlled Trial
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wasuchon Chaichan, MD
- 전화번호: +66949749616
- 이메일: wasuchon.ch@gmail.com
연구 연락처 백업
- 이름: Chonlawat Chaichan, MSc
- 이메일: wasuchon.ch@gmail.com
연구 장소
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Changwat Phayao
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Phayao, Changwat Phayao, 태국, 56000
- University of Phayao Hospital
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수석 연구원:
- Wasuchon Chaichan, MD
-
연락하다:
- Wasuchon Chaichan, MD
- 전화번호: 0949749616
- 이메일: wasuchon.ch@gmail.com
-
연락하다:
-
부수사관:
- Chonlawat Chaichan, MSc
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Pentoxifylline Add-On Therapy
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.
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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.
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위약 비교기: Placebo Add-On Therapy
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.
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Achieving PASI 50
기간: Week 12
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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.
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Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Achieving PASI 75
기간: Week 12
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Proportion of participants who achieve at least a 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score.
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Week 12
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Proportion of Participants Achieving PASI 90
기간: Week 12
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Proportion of participants who achieve at least a 90% reduction from baseline in Psoriasis Area and Severity Index (PASI) score.
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Week 12
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Percent Change in PASI Score From Baseline
기간: Baseline to Week 12
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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.
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Baseline to Week 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wasuchon Chaichan, MD, University of Phayao
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HREC-UP-HSST 1.3/032/69
- MD69-10 (기타 보조금/기금 번호: School of Medicine, University of Phayao)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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