Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis
Crisaborole 2% Versus Tacrolimus 0.03% Ointments for the Treatment of Mild to Moderate Atopic Dermatitis: A Comparative Study
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
This study will compare the efficacy and safety of crisaborole ointment with tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2026
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2025
CompletedFirst Posted
Study publicly available on registry
January 26, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedJanuary 26, 2026
January 1, 2026
2 months
December 28, 2025
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement of Investigator's Static Global Assessment score
1. Assessment of the \*\*Investigator's Static Global Assessment\*\* scores before and after treatment with crisaborole 2% ointment. 2. Assessment of the \*\*Investigator's Static Global Assessment\*\* before and after treatment with tacrolimus 0.03% ointment. 3. Comparison of the \*\*percentage of improvement\*\* in the \*\*Investigator's Static Global Assessment\*\* between the two treatment groups.
3 months
Improvement of Eczema Area and Severity Index
1. Assessment of \*\*Eczema Area and Severity Index\*\* scores before and after the use of \*\*crisaborole 2% ointment\*\*. 2. Assessment of \*\*Eczema Area and Severity Index\*\* scores before and after the use of \*\*tacrolimus 0.03% ointment\*\*. 3. Comparison of the percentage of improvement in the \*\*Eczema Area and Severity Index\*\* scores between the two treatment groups
3 months
Study Arms (2)
Crisaborole ointment
ACTIVE COMPARATORTacrolimus ointment
ACTIVE COMPARATORInterventions
compare the efficacy and safety of tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis
compare the efficacy and safety of crisaborole ointment on mild to moderate atopic dermatitis for 1 month and followup in 2 months
Eligibility Criteria
You may qualify if:
- Patients with diagnosis of AD, according to Hanifin and Rajka criteria.
- Patients of both genders
- Age 5-25 years
- Baseline Investigator's Static Global Assessment (ISGA) score of mild (2) or moderate (3).
You may not qualify if:
- Clinically infected eczema.
- Baseline Investigator's Static Global Assessment (ISGA) score of severe (4).
- Associated comorbidities that exacerbate pruritus.
- Patients receiving topical treatment for AD and/or pruritus within the past 14 days and/or systemic treatment within the past month.
- Pregnancy and lactation if in the childbearing period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
December 28, 2025
First Posted
January 26, 2026
Study Start
February 1, 2026
Primary Completion
April 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
January 26, 2026
Record last verified: 2026-01