Psoriasis (PsO)
Conditions
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
Interventions
Topical betamethasone dipropionate 0.05% cream once daily applied to affected plaque psoriasis lesions twice daily for up to 4 weeks
Topical tapinarof 1% cream applied once daily to affected skin areas for up to 12 weeks
Sponsors
Pakistan Institute of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving a 75% reduction from baseline in psoriasis area and severity index(PASI 75) | 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. |
Countries
Pakistan
Contacts
CONTACTNoor Ul Ain, PGT Dermatology
Outcome results
None listed