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

NCT07162896 | Not Yet Recruiting Phase 3

• 1 other identifier: Kheziema Maryum
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28.

  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.

  Baseline, Day 14, Day 28

Study Arms (2)

Crisaborole 2% Ointment

ACTIVE COMPARATOR

Twice daily application to affected areas for 28 days

Drug: Crisaborole 2%

Tacrolimus 0.1% Ointment

ACTIVE COMPARATOR

Twice daily application to affected areas for 28 days

Drug: Tacrolimus 0.1%

Interventions

Crisaborole 2% DRUG

Apply thin layer to affected skin daily for 28 days.

Crisaborole 2% Ointment

Tacrolimus 0.1% DRUG

Apply thin layer to affected skin daily for 28 days.

Tacrolimus 0.1% Ointment

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 2-18 years Both genders Clinically diagnosed mild to moderate atopic dermatitis Body surface area (BSA) \<30%

You may not qualify if:

• 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

Sponsors & Collaborators

• Shalamar Institute of Health Sciences: lead

Study Sites (1)

Shalamar Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Kheziema Maryum

CONTACT

0310-4999940; doc.kheziemamaryum@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)