Psoriasis (PsO)Phase 4NCT07635043
Efficacy of Topical Tapinarof Versus Betamethasone in the Treatment of Plaque Psoriasis
A Phase 4 study testing Betamethasone Dipropionate 0.05% Cream and Tapinarof Cream 1% in people with Psoriasis (PsO), run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
To assess the effectiveness of topical tapinarof to topical betamethasone in patients with mild to moderate plaque psoriasis presenting to tertiary care hospital in Islamabad Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis (PsO)
- What is being tested?
- Betamethasone Dipropionate 0.05% Cream and Tapinarof Cream 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2026to 30 Nov 2026
- Phase
- Phase 4
- 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
- Age 18 years-65 years
- Clinically diagnosed plaque psoriasis involving body surface area ( BSA) of 2-20% (mild to moderate severity)
- Disease duration of at least 6 months
- Willing and able to provide written informed consent
- Not currently using any other topical and systematic psoriasis therapy, or willing to undergo a washout period (2 weeks for topical therapies)
Who cannot join
- Severe psoriasis (BSA >20% or requiring systemic therapy)
- Pregnant and lactating mothers
- Known hypersensitivity to Tapinarof or any of its excipients
- Concurrent dermatological conditions that may interfere with assessment e.g fungal infections,atopic dermatitis
- Use of systemic immunosuppressants (methotrexate, cyclosporine, biologics ) or phototherapy within 4 weeks before enrollment
- History of malignancy or current active infection
- Known hypersensitivity to betamethasone or Tapinarof
- Use of powerful topical corticosteroids within two weeks previously
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pakistan institute of medical sciences(PIMS)
Islamabad, Federal, 44000
Clinical research coordinator, 0519261170, Info@pims.gov.pk
About this study
To assess the effectiveness of topical tapinarof to topical betamethasone in patients with mild to moderate plaque psoriasis presenting to tertiary care hospital in Islamabad
- Conditions
- Psoriasis (PsO)
- Being tested
- Betamethasone Dipropionate 0.05% Cream, Tapinarof Cream 1%
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Dipropionate 0.05% CreamDrug
Topical betamethasone dipropionate 0.05% cream once daily applied to affected plaque psoriasis lesions twice daily for up to 4 weeks
Tapinarof Cream 1%Drug
Topical tapinarof 1% cream applied once daily to affected skin areas for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tapinarof 1% cream | Experimental | Participants will apply topical tapinarof 1% cream once daily to effected plaque psoriasis Receives: Drug: Tapinarof Cream 1% |
| Betamethasone dipropionate 0.05% | Active comparator | Participants will apply topical betamethasone dipropionate 0.05% cream/ointment twice daily to effected plaque psoriasis lesions Receives: Drug: Betamethasone Dipropionate 0.05% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving a 75% reduction from baseline in psoriasis area and severity index(PASI 75)
The psoriasis area and severity index(PASI) quantifies the severity of psoriasis plaques and the total body surface area affected.It combines assessments of plaque erythema, induration and desquamation across four body regions (head, trunk, upper limbs, lower limbs ) into a score ranging from 0 ( no disease) to 72 ( severe disease) .PASI 75 represents a 75% or greater reduction ( improvement) in the total PASI score compared to the participants baseline value.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a quasi-experimental research(with a single pre-test/post-test group).A quasi-experimental design is acceptable since all eligible patients will get the active intervention (tapinarof) without a placebo control group,which is typical in real world clinical practice.The primary outcome (PASI score) will be assessed at baseline and three follow-up points (weeks 4,8 and 12), allowing for within-subject comparison.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noor Ul Ain, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635043
- Sponsor's protocol ID
- Tapinarof vs betamethasone
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Tapinarof Versus Betamethasone in the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07635043
- Acronym / sponsor ID
- Tapinarof vs betamethasone
- Conditions
- Psoriasis (PsO)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 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.
To assess the effectiveness of topical tapinarof to topical betamethasone in patients with mild to moderate plaque psoriasis presenting to tertiary care hospital in Islamabad
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental research(with a single pre-test/post-test group).A quasi-experimental design is acceptable since all eligible patients will get the active intervention (tapinarof) without a placebo control group,which is typical in real world clinical practice.The primary outcome (PASI score) will be assessed at baseline and three follow-up points (weeks 4,8 and 12), allowing for within-subject comparison.
| Arm | Type | Receives |
|---|---|---|
| Tapinarof 1% cream | Experimental | Drug: Tapinarof Cream 1%Participants will apply topical tapinarof 1% cream once daily to effected plaque psoriasis |
| Betamethasone dipropionate 0.05% | Active comparator | Drug: Betamethasone Dipropionate 0.05% CreamParticipants will apply topical betamethasone dipropionate 0.05% cream/ointment twice daily to effected plaque psoriasis lesions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years-65 years
- Clinically diagnosed plaque psoriasis involving body surface area ( BSA) of 2-20% (mild to moderate severity)
- Disease duration of at least 6 months
- Willing and able to provide written informed consent
- Not currently using any other topical and systematic psoriasis therapy, or willing to undergo a washout period (2 weeks for topical therapies)
Key exclusion criteria (8 listed)
- Severe psoriasis (BSA >20% or requiring systemic therapy)
- Pregnant and lactating mothers
- Known hypersensitivity to Tapinarof or any of its excipients
- Concurrent dermatological conditions that may interfere with assessment e.g fungal infections,atopic dermatitis
- Use of systemic immunosuppressants (methotrexate, cyclosporine, biologics ) or phototherapy within 4 weeks before enrollment
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 |
|---|---|---|
| Betamethasone Dipropionate 0.05% CreamTopical betamethasone dipropionate 0.05% cream once daily applied to affected plaque psoriasis lesions twice daily for up to 4 weeks | Drug | Betamethasone dipropionate 0.05% |
| Tapinarof Cream 1%Topical tapinarof 1% cream applied once daily to affected skin areas for up to 12 weeks | Drug | Tapinarof 1% cream |
Primary outcome
Percentage of participants achieving a 75% reduction from baseline in psoriasis area and severity index(PASI 75)
Time frame: 12 weeks
The psoriasis area and severity index(PASI) quantifies the severity of psoriasis plaques and the total body surface area affected.It combines assessments of plaque erythema, induration and desquamation across four body regions (head, trunk, upper limbs, lower limbs ) into a score ranging from 0 ( no disease) to 72 ( severe disease) .PASI 75 represents a 75% or greater reduction ( improvement) in the total PASI score compared to the participants baseline value.
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 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Psoriasis (PsO)
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruiting
Definition of Novel Optoacoustic Biomarkers of Psoriasis and Psoriatic Arthritis
Psoriasis (PsO), Psoriasis Arthritis
Not yet recruitingObservational study
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
Plaque Psoriasis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betamethasone Dipropionate 0.05% Cream and Tapinarof Cream 1% in people with Psoriasis (PsO), run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 9 Jun 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Noor Ul Ain, PGT Dermatology (+923365788143, nooraftab146@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving a 75% reduction from baseline in psoriasis area and severity index(PASI 75) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.