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NCT Number: NCT07713186

Azithromycin in Atopic Dermatitis

The study will evaluate the role of adding azithromycin to topical treatment in patients with mild to moderate atopic dermatitis

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Both genders, ages from 3 to 12 years old with mild to moderate atopic dermatitis

Exclusion criteria

  • Atopic dermatitis on active systemic treatment

Treatment and study plan

Betamethasone or tacrolimus ointments

Drug

Topical treatment will be applied, Betamethasone or tacrolimus ointments

Azithromycin

Drug

Azithromycin will be combined with topical treatment

Primary outcomes

  1. Improvement in Eczema Area and Severity Index (EASI)

    Time frame: 3 months

    The primary outcome will be the change in the Eczema Area and Severity Index (EASI) score from baseline to the end of the treatment period. The EASI is a validated clinician-assessed tool that evaluates the severity and extent of atopic dermatitis by assessing erythema, edema/papulation, excoriation, and lichenification across four body regions. Scores range from 0 to 72, with higher scores indicating more severe disease.

    Outcome variable: Mean change in EASI score from baseline. Assessment time points: Baseline, Week 2, Week 4, Week 8, and end of follow-up. Treatment response: Proportion of patients achieving EASI-50, EASI-75, and EASI-90 (≥50%, ≥75%, and ≥90% improvement from baseline).

Secondary outcomes

  1. Investigator's Global Assessment (IGA)

    Time frame: 4 months

    The Investigator's Global Assessment will be used to evaluate the overall clinical severity of atopic dermatitis.

    Scale:

    0 = Clear

    • = Almost clear
    • = Mild
    • = Moderate
    • = Severe

    Outcome variables:

    Mean change in IGA score. Percentage of patients achieving IGA 0/1 (clear or almost clear).

  2. Pruritus Severity

    Time frame: 3

    Pruritus will be assessed using a 10-cm Visual Analog Scale (VAS) or Numeric Rating Scale (NRS, 0-10).

    0 = No itch 10 = Worst imaginable itch

    Outcome:

    Mean reduction in pruritus score.

Study contacts

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

Amira Elbendary, MD

CONTACT

[email protected]

+201552208664

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of the Value of Adding Azithromycin to Topical Treatment in Mild to Moderate Atopic Dermatitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 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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