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NCT Number: NCT07367932

Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of crisaborole twice daily

Drug

compare the efficacy and safety of crisaborole ointment on mild to moderate atopic dermatitis for 1 month and followup in 2 months

Tacrolimus ointment in atopic dermatitis

Drug

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

Primary outcomes

  1. Improvement of Investigator's Static Global Assessment score

    Time frame: 3 months

    • Assessment of the **Investigator's Static Global Assessment** scores before and after treatment with crisaborole 2% ointment.
    • Assessment of the **Investigator's Static Global Assessment** before and after treatment with tacrolimus 0.03% ointment.
    • Comparison of the **percentage of improvement** in the **Investigator's Static Global Assessment** between the two treatment groups.

  2. Improvement of Eczema Area and Severity Index

    Time frame: 3 months

    • Assessment of **Eczema Area and Severity Index** scores before and after the use of **crisaborole 2% ointment**.
    • Assessment of **Eczema Area and Severity Index** scores before and after the use of **tacrolimus 0.03% ointment**.
    • Comparison of the percentage of improvement in the **Eczema Area and Severity Index** scores between the two treatment groups

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Raafat Khalil, MBBcH

CONTACT

[email protected]

+201120807903

Rana Ahmed Mosaad, MD

CONTACT

[email protected]

+201096344429

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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