Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis; Atopic Dermatitis (AD)
• Interventions: Drug: Crisaborole 2%; Drug: Tacrolimus 0.1%

• Registration Number: NCT07162896
• Lead Sponsor: Shalamar Institute of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-31
• Study First Submitted QC: 2025-08-31
• Last Update Submitted: 2025-08-31
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2026-06-01
• Primary Completion: 2027-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crisaborole 2% Ointment	Crisaborole 2%	Twice daily application to affected areas for 28 days
Tacrolimus 0.1% Ointment	Tacrolimus 0.1%	Twice daily application to affected areas for 28 days

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shalamar Hospital Lahore; 🇵🇰 Lahore, Punjab Province, Pakistan