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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07367932

Enrollment

Registered

2026-01-26

Start date

2026-02-01

Completion date

2026-07-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic, Eczema

Keywords

Tacrolimus, Crisaborole, Atopic dermatitis

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.

Interventions

DRUGApplication 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

DRUGTacrolimus ointment in atopic dermatitis

compare the efficacy and safety of tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 25 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement of Investigator's Static Global Assessment score	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.
Improvement of Eczema Area and Severity Index	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

Contacts

CONTACTAya Raafat Khalil, MBBcH

ayah.rafaat.97@gmail.com+201120807903

CONTACTRana Ahmed Mosaad, MD

ranaahmedmosaad@gmail.com+201096344429

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026