Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-18
SponsorShalamar Institute of Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 2-18 years Both genders Clinically diagnosed mild to moderate atopic dermatitis Body surface area (BSA) <30%
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Crisaborole 2%
DrugApply thin layer to affected skin daily for 28 days.
Tacrolimus 0.1%
DrugApply thin layer to affected skin daily for 28 days.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Crisaborole 2% OintmentActive comparator 1 intervention
Group B: Tacrolimus 0.1% OintmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28.
Time frame
28 days2
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.
Time frame
Baseline, Day 14, Day 28Sponsors and contacts
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Source ClinicalTrials.gov
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