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

Phase 3Not Yet RecruitingNCT07162896

Shalamar Institute of Health Sciences66 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis Atopic Dermatitis (AD)

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

ISGA uses a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe); negative change indicates improvement.

Time frame: Baseline, Day 14, Day 28