Atopic DermatitisPhase 4NCT07713186
Azithromycin in Atopic Dermatitis
A Phase 4 study testing Betamethasone or tacrolimus ointments and Azithromycin in people with Atopic Dermatitis, run by Cairo University at 1 site in Egypt.
Trial summary
The study will evaluate the role of adding azithromycin to topical treatment in patients with mild to moderate atopic dermatitis Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Betamethasone or tacrolimus ointments and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both genders, ages from 3 to 12 years old with mild to moderate atopic dermatitis
Who cannot join
- Atopic dermatitis on active systemic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo, Saray, 11562
Amira Elbendary, MD, +201555668584, aelbendary@kasralainy.edu.eg
About this study
Official title: Evaluation of the Value of Adding Azithromycin to Topical Treatment in Mild to Moderate Atopic Dermatitis
The study will evaluate the role of adding azithromycin to topical treatment in patients with mild to moderate atopic dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- Betamethasone or tacrolimus ointments, Azithromycin
- Keywords
- Atopic dermatitis, Azithromycin
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone or tacrolimus ointmentsDrug
Topical treatment will be applied, Betamethasone or tacrolimus ointments
AzithromycinDrug
Azithromycin will be combined with topical treatment
| Study group | Role | What they receive |
|---|---|---|
| Topical corticosteroids and tacrolimus | Active comparator | Atopic dermatitis patients on topical betamethasone and tacrolimus ointments Receives: Drug: Betamethasone or tacrolimus ointments |
| Azithromycin | Experimental | Atopic dermatitis treated with azithromycin besides topical betamethasone and tacrolimus ointments Receives: Drug: Betamethasone or tacrolimus ointments; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (2)
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
- = Almost clear
- = Mild
- = Moderate
- = Severe
Outcome variables:
Mean change in IGA score. Percentage of patients achieving IGA 0/1 (clear or almost clear).
Measured: 4 months
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.
Measured: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Elbendary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713186
- Sponsor's protocol ID
- MS-121-2026
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Value of Adding Azithromycin to Topical Treatment in Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07713186
- Acronym / sponsor ID
- MS-121-2026
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Azithromycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the role of adding azithromycin to topical treatment in patients with mild to moderate atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical corticosteroids and tacrolimus | Active comparator | Drug: Betamethasone or tacrolimus ointmentsAtopic dermatitis patients on topical betamethasone and tacrolimus ointments |
| Azithromycin | Experimental | Drug: Betamethasone or tacrolimus ointments, Drug: AzithromycinAtopic dermatitis treated with azithromycin besides topical betamethasone and tacrolimus ointments |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Both genders, ages from 3 to 12 years old with mild to moderate atopic dermatitis
Key exclusion criteria (1 listed)
- Atopic dermatitis on active systemic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethasone or tacrolimus ointmentsTopical treatment will be applied, Betamethasone or tacrolimus ointments | Drug | Azithromycin, Topical corticosteroids and tacrolimus |
| AzithromycinAzithromycin will be combined with topical treatment | Drug | Azithromycin |
Primary outcome
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).
2 secondary outcomes
Investigator's Global Assessment (IGA)
Time frame: 4 months
Pruritus Severity
Time frame: 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betamethasone or tacrolimus ointments and Azithromycin in people with Atopic Dermatitis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Elbendary, MD (+201552208664, aelbendary@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Eczema Area and Severity Index (EASI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.