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

Shalamar Institute of Health Sciences

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Atopic Dermatitis; Atopic Dermatitis (AD)

Treatments: Drug: Crisaborole 2%; Drug: Tacrolimus 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT07162896

Kheziema Maryum

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Crisaborole 2% Ointment

Active Comparator group

Description:

Twice daily application to affected areas for 28 days

Treatment:

Drug: Crisaborole 2%

Tacrolimus 0.1% Ointment

Active Comparator group

Description:

Twice daily application to affected areas for 28 days

Treatment:

Drug: Tacrolimus 0.1%