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NCT Number: NCT07162896

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

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.

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Key information

Conditions

Atopic Dermatitis Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shalamar Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location contact

Shalamar Hospital Lahore Shalamar Hospital Lahore

CONTACT

[email protected]

(042)111205205

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crisaborole 2%

Drug

Apply thin layer to affected skin daily for 28 days.

tacrolimus 0.1%

Drug

Apply thin layer to affected skin daily for 28 days.

Primary outcomes

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

    Time frame: 28 days

  2. Change in ISGA from baseline to day 28.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kheziema Maryum

CONTACT

[email protected]

0310-4999940

Sponsors and collaborators

Lead sponsor

Shalamar Institute of Health Sciences

Other

Registry information

Official study title

Efficacy and Safety of Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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