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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPakistan Institute of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Tapinarof 1% creamExperimental treatment 1 intervention
Group B: Betamethasone dipropionate 0.05%Active comparator 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: