Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Crisaborole 2%, Tacrolimus 0.1%.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Atopic Dermatitis (AD). Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
Overview
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
- Drug Crisaborole 2%
Apply thin layer to affected skin daily for 28 days. - Drug Tacrolimus 0.1%
Apply thin layer to affected skin daily for 28 days.
Primary outcome measures
- Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28. [Time frame: 28 days]
- Change in ISGA from baseline to day 28. [Time frame: Baseline, Day 14, Day 28]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Shalamar Hospital Lahore — Lahore
Identifiers
NCT: NCT07162896 · Kheziema Maryum