PsoriasisPTX-PSONCT07626788
Pentoxifylline Add-On Therapy for Mild-to-Moderate Plaque Psoriasis
A study testing Pentoxifylline 400 mg Oral Tablet in people with Psoriasis, run by Wasuchon Chaichan at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Pentoxifylline 400 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chonlawat Chaichan, MSc contact
Thailand1 site
University of Phayao Hospital
Phayao, Changwat Phayao, 56000
Wasuchon Chaichan, MD, 0949749616, wasuchon.ch@gmail.com
wasuchon.ch@gmail.com
About this study
Official title: Efficacy and Safety of Pentoxifylline as Add-On Therapy for Mild-to-Moderate Plaque Psoriasis: A Double-Blind Randomized Placebo-Controlled 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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Pentoxifylline 400 mg Oral Tablet, Placebo
- Keywords
- Plaque Psoriasis, Pentoxifylline, Add-On Therapy, Randomized Controlled Trial, Placebo-Controlled Trial
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline 400 mg Oral TabletDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (3)
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.
Measured: Week 12
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.
Measured: 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wasuchon Chaichan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wasuchon Chaichan, University of Phayao
- Investigators
- Wasuchon Chaichan, MD, Principal investigator, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626788
- Sponsor's protocol ID
- HREC-UP-HSST 1.3/032/69
- Other IDs
- MD69-10
- Acronym
- PTX-PSO
- Status last verified
- Oct 2026
- First submitted
- 31 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25396144el-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.
PubMed 20073999Magela 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.
PubMed 17085994
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pentoxifylline as Add-On Therapy for Mild-to-Moderate Plaque Psoriasis: A Double-Blind Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07626788
- Acronym / sponsor ID
- PTX-PSO / HREC-UP-HSST 1.3/032/69
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, Pentoxifylline, Add-On Therapy, Randomized Controlled Trial, Placebo-Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Wasuchon ChaichanUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline Add-On Therapy | Active comparator | Drug: Pentoxifylline 400 mg Oral TabletParticipants 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 | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline 400 mg Oral TabletPentoxifylline 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. | Drug | Pentoxifylline Add-On Therapy |
| PlaceboMatching 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. | Drug | Placebo Add-On Therapy |
Primary outcome
Proportion of Participants Achieving PASI 50
Time frame: 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.
3 secondary outcomes
Proportion of Participants Achieving PASI 75
Time frame: Week 12
Proportion of Participants Achieving PASI 90
Time frame: Week 12
Percent Change in PASI Score From Baseline
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 25396144Hassan 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.
- Background: PubMed 20073999el-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.
- Background: PubMed 17085994Magela 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chonlawat Chaichan, MSc contact
Wasuchon Chaichan, MD principal investigator
University of Phayao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline 400 mg Oral Tablet in people with Psoriasis, run by Wasuchon Chaichan at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wasuchon Chaichan, MD (+66949749616, wasuchon.ch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving PASI 50 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07626788, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.