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

Sponsor
Shalamar Institute of Health Sciences
Study ID
NCT07162896
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 9, 2025
Start date
Jun 30, 2026
Status verified
Aug 2025
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Crisaborole 2% Ointment
    Twice daily application to affected areas for 28 days
  • Active Comparator: Tacrolimus 0.1% Ointment
    Twice daily application to affected areas for 28 days

Primary Outcome Measure

Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28. [ Time Frame: 28 days ]

Central Contacts

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Nationwide
Atopic dermatitis / eczema trialsDermatology trialsRheumatology trialsAutoimmune disease trials

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