Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, Azithromycin
Brief summary
The study will evaluate the role of adding azithromycin to topical treatment in patients with mild to moderate atopic dermatitis
Interventions
DRUGBetamethasone or tacrolimus ointments
Topical treatment will be applied, Betamethasone or tacrolimus ointments
DRUGAzithromycin
Azithromycin will be combined with topical treatment
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Eczema Area and Severity Index (EASI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) | 4 months | 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). |
| Pruritus Severity | 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. |
Countries
Egypt
Contacts
CONTACTAmira Elbendary, MD
Outcome results
None listed