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Not yet recruitingNCT07713186Updated Jul 20, 2026

Azithromycin in Atopic Dermatitis

A Phase 4 interventional study of Betamethasone or tacrolimus ointments and Azithromycin in Atopic Dermatitis, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 12 Years
Sex
All
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Study summary

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

02

Conditions studied

  • Atopic Dermatitis

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Keywords

  • Atopic dermatitis
  • Azithromycin
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 40 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Atopic dermatitis on active systemic treatment
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Topical corticosteroids and tacrolimus

    Atopic dermatitis patients on topical betamethasone and tacrolimus ointments

    Drug: Betamethasone or tacrolimus ointments

  • Experimental
    Azithromycin

    Atopic dermatitis treated with azithromycin besides topical betamethasone and tacrolimus ointments

    Drug: Betamethasone or tacrolimus ointments · Drug: Azithromycin

Interventions

  • DrugBetamethasone or tacrolimus ointments

    Topical treatment will be applied, Betamethasone or tacrolimus ointments

  • DrugAzithromycin

    Azithromycin will be combined with topical treatment

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: 3 months

Secondary outcomes

  1. Investigator's Global Assessment (IGA)

    The Investigator's Global Assessment will be used to evaluate the overall clinical severity of atopic dermatitis. Scale: 0 = Clear 1. = Almost clear 2. = Mild 3. = Moderate 4. = Severe Outcome variables: Mean change in IGA score. Percentage of patients achieving IGA 0/1 (clear or almost clear).

    Time frame: 4 months

  2. Pruritus Severity

    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.

    Time frame: 3

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07713186
Lead sponsor
Cairo University
Responsible party
Amira Elbendary (Lecturer, Cairo University) — Principal investigator
First posted
Jul 20, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 20, 2026

Study contacts

Amira Elbendary, MD
Contact
aelbendary@kasralainy.edu.eg
+201552208664

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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