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

NCT ID: NCT07162896

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Atopic Dermatitis Atopic Dermatitis (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crisaborole 2% Ointment

Twice daily application to affected areas for 28 days

Group Type ACTIVE_COMPARATOR

Crisaborole 2%

Intervention Type DRUG

Apply thin layer to affected skin daily for 28 days.

Tacrolimus 0.1% Ointment

Twice daily application to affected areas for 28 days

Group Type ACTIVE_COMPARATOR

Tacrolimus 0.1%

Intervention Type DRUG

Apply thin layer to affected skin daily for 28 days.

Interventions

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Crisaborole 2%

Apply thin layer to affected skin daily for 28 days.

Intervention Type DRUG

Tacrolimus 0.1%

Apply thin layer to affected skin daily for 28 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shalamar Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Kheziema Maryum

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shalamar Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Kheziema Maryum

Role: CONTACT

0310-4999940

Facility Contacts

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Shalamar Hospital Lahore Shalamar Hospital Lahore

Role: primary

(042)111205205

Other Identifiers

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Kheziema Maryum

Identifier Type: -

Identifier Source: org_study_id

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