Efficacy of Topical Tapinarof Versus Betamethasone in the Treatment of Plaque Psoriasis

NCT07635043 | Not Yet Recruiting Phase 4

• 1 other identifier: Tapinarof vs betamethasone
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Psoriasis (PsO)

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

Tapinarof 1% cream

EXPERIMENTAL

Participants will apply topical tapinarof 1% cream once daily to effected plaque psoriasis

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

Drug: Betamethasone Dipropionate 0.05% Cream

Interventions

Betamethasone Dipropionate 0.05% Cream DRUG

Topical betamethasone dipropionate 0.05% cream once daily applied to affected plaque psoriasis lesions twice daily for up to 4 weeks

Betamethasone dipropionate 0.05%

Tapinarof Cream 1% DRUG

Topical tapinarof 1% cream applied once daily to affected skin areas for up to 12 weeks

Tapinarof 1% cream

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Pakistan institute of medical sciences(PIMS)

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Psoriasis

Interventions

betamethasone-17,21-dipropionate

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Noor Ul Ain, PGT Dermatology

CONTACT

+923365788143; nooraftab146@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology resident

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)