Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis

January 20, 2026 updated by: Amira Elbendary, Cairo University

Crisaborole 2% Versus Tacrolimus 0.03% Ointments for the Treatment of Mild to Moderate Atopic Dermatitis: A Comparative Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Crisaborole ointment
Drug: Application of crisaborole twice daily
compare the efficacy and safety of crisaborole ointment on mild to moderate atopic dermatitis for 1 month and followup in 2 months
Active Comparator: Tacrolimus ointment
Drug: Tacrolimus ointment in atopic dermatitis
compare the efficacy and safety of tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Investigator's Static Global Assessment score
Time Frame: 3 months
  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
Time Frame: 3 months
  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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-61-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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