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NCT Number: NCT07635043

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pakistan institute of medical sciences(PIMS)

Islamabad, Federal, 44000, Pakistan

Location contact

Clinical research coordinator

CONTACT

[email protected]

0519261170

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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

Tapinarof Cream 1%

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Noor Ul Ain, PGT Dermatology

CONTACT

[email protected]

+923365788143

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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