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Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema

Study acronym: CRISA-AD
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record status
This record was last updated March 6, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Eligibility criteria shortened, about 2 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life. Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.
Trial Details
NCT Number NCT07438509
Lead Sponsor Jinnah Postgraduate Medical Centre
Conditions
(from sponsor)		 Atopic Dermatitis (AD), Atopic Eczema
Related terms Dermatitis, Atopic
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov