Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Dermatitis, Atopic; Eczema

Treatments: Drug: Tacrolimus ointment in atopic dermatitis; Drug: Application of crisaborole twice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07367932

MS-61-2025

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 25 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Crisaborole ointment

Active Comparator group

Treatment:

Drug: Application of crisaborole twice daily

Tacrolimus ointment

Active Comparator group

Treatment:

Drug: Tacrolimus ointment in atopic dermatitis