Atopic Dermatitis, Atopic Dermatitis (AD)
Conditions
Brief summary
This randomized, open-label, parallel-group study will compare the efficacy and safety of Crisaborole 2% ointment and Tacrolimus 0.1% ointment in children with mild to moderate atopic dermatitis. A total of 66 participants will be randomized (1:1) to receive either Crisaborole or Tacrolimus, applied twice daily to affected areas for 28 days. Primary endpoint is proportion of participants achieving Investigator's Static Global Assessment (ISGA) success (clear/almost clear with ≥2-point improvement from baseline) at Day 28. Safety assessments include adverse events and local application site reactions.
Interventions
DRUGCrisaborole 2%
Apply thin layer to affected skin daily for 28 days.
DRUGTacrolimus 0.1%
Apply thin layer to affected skin daily for 28 days.
Sponsors
Shalamar Institute of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 2-18 years Both genders Clinically diagnosed mild to moderate atopic dermatitis Body surface area (BSA) \<30%
Exclusion criteria
Active viral, bacterial, or fungal skin infection at the treatment site Recent use of topical corticosteroids, calcineurin inhibitors, PDE4 inhibitors, or immunosuppressive medication within past 2 weeks Known hypersensitivity to study medications or components Chronic inflammatory conditions (e.g., psoriasis and seborrheic dermatitis) that may interfere with evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28. | 28 days | — |
| Change in ISGA from baseline to day 28. | Baseline, Day 14, Day 28 | ISGA uses a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe); negative change indicates improvement. |
Countries
Pakistan
Contacts
Primary ContactKheziema Maryum
Outcome results
None listed