Efficacy and Safety of Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
Sponsor study identifier
interventional
66
1 country
1
Study Start
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2025
Actual (reported)September 9, 2025
Actual (reported)June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Twice daily application to affected areas for 28 days
Twice daily application to affected areas for 28 days
Shalamar Hospital Lahore
Lahore, Punjab Province, 54000, Pakistan
First Submitted
August 31, 2025
First Posted
September 9, 2025
Study Start
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2027
Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 9, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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