Acne VulgarisNCT07777952
Adjunctive 308-nm Excimer Light With Oral Azithromycin for Inflammatory Acne
A study testing 308-nm Excimer Light and Azithromycin in people with Acne Vulgaris, run by Mahmoud Rageh at 1 site in Egypt.
Trial summary
This randomized, evaluator-blinded, split-face study evaluated whether adjunctive lesion-directed 308-nm excimer light improves inflammatory acne outcomes during oral azithromycin therapy. All participants received oral azithromycin 500 mg three times weekly for 8 weeks. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 308-nm Excimer Light and Azithromycin
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2025to 10 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female participants.
- age 15-35 years.
- Bilateral inflammatory acne involving both hemifaces, with clinically comparable baseline inflammatory involvement as assessed before randomization.
- No topical or systemic acne treatment during the preceding 8 weeks.
Who cannot join
- Pregnancy.
- Photosensitivity disorders.
- Macrolide hypersensitivity.
- Concurrent isotretinoin use or isotretinoin use during the preceding 8 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Adjunctive 308-nm Excimer Light During Oral Azithromycin Therapy for Inflammatory Acne Vulgaris: A Randomized, Evaluator-Blinded, Split-Face Controlled Trial
This randomized, evaluator-blinded, split-face study evaluated whether adjunctive lesion-directed 308-nm excimer light improves inflammatory acne outcomes during oral azithromycin therapy. All participants received oral azithromycin 500 mg three times weekly for 8 weeks. One randomly allocated hemiface additionally received 308-nm excimer light twice weekly for 8 weeks, while the contralateral hemiface served as the azithromycin-only control. Papule and pustule counts and hemiface Investigator's Global Assessment were assessed through Week 8. Investigator's Global Assessment was reassessed at Week 16 after an 8-week treatment-free follow-up. We hypothesized that the excimer-treated hemiface would demonstrate greater reduction in total inflammatory-lesion count by Week 8.
Read the detailed description
Participants with bilateral inflammatory acne received oral azithromycin 500 mg after meals three times weekly for 8 weeks. One hemiface was randomized by coin toss to receive adjunctive lesion-directed 308-nm excimer light twice weekly for 8 weeks; the contralateral hemiface received no irradiation. The primary outcome was the within-participant between-side difference in change from baseline to Week 8 in total inflammatory lesion count, defined as papules plus pustules. Hemiface IGA was assessed through Week 16, following an 8-week treatment-free period.
- Conditions
- Acne Vulgaris
- Being tested
- 308-nm Excimer Light, Azithromycin
- Keywords
- Inflammatory acne, 308-nm excimer light, Azithromycin, Phototherapy, Split-face
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
308-nm Excimer LightDevice
Monochromatic 308-nm excimer light was delivered using the KN-5000C device. Irradiation was lesion-directed and administered twice weekly for 8 weeks, with at least 48 hours between sessions, for a planned total of 16 sessions. Treatment began at 0.15 J/cm² and was increased according to erythema response and device dose settings, up to a maximum of 0.65 J/cm².
AzithromycinDrug
Description: Oral azithromycin 500 mg was administered after meals three times weekly for 8 weeks, corresponding to 24 scheduled doses.
| Study group | Role | What they receive |
|---|---|---|
| Excimer Light Plus Oral Azithromycin Hemiface | Experimental | One randomly allocated hemiface received lesion-directed 308-nm excimer light twice weekly for 8 weeks in addition to the oral azithromycin received by all participants. Receives: Device: 308-nm Excimer Light; Drug: Azithromycin |
| Oral Azithromycin Only Hemiface | Active comparator | The contralateral hemiface received no excimer-light irradiation. All participants received oral azithromycin for 8 weeks. Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Inflammatory-Lesion Count at Week 8
Papules and pustules were counted separately for each hemiface by a blinded evaluator. Total inflammatory-lesion count was calculated as the sum of papules and pustules. Change was calculated as the baseline count minus the Week-8 count; positive values indicated improvement. The primary comparison was the within-participant difference in change between the excimer-treated and control hemifaces.
Measured: Baseline and Week 8
Secondary outcomes (8)
Change From Baseline in Papule Count at Week 8
Papules were counted separately for each hemiface by a blinded evaluator. Change was calculated as the baseline count minus the Week-8 count; positive values indicated improvement.
Measured: Baseline and Week 8
Change From Baseline in Pustule Count at Week 8
Pustules were counted separately for each hemiface by a blinded evaluator. Change was calculated as the baseline count minus the Week-8 count; positive values indicated improvement.
Measured: Baseline and Week 8
Percentage Reduction in Total Inflammatory-Lesion Count at Week 8
Percentage reduction was calculated separately for each hemiface as 100 × (baseline total inflammatory-lesion count minus Week-8 total inflammatory-lesion count) divided by the baseline count. Higher percentages indicated greater improvement.
Measured: Baseline and Week 8
Proportion of Hemifaces With at Least 50% Reduction in Total Inflammatory-Lesion Count
A responder was defined as a hemiface achieving at least a 50% reduction in total inflammatory-lesion count from baseline to Week 8.
Measured: Baseline and Week 8
Proportion of Hemifaces With at Least 80% Reduction in Total Inflammatory-Lesion Count
A responder was defined as a hemiface achieving at least an 80% reduction in total inflammatory-lesion count from baseline to Week 8.
Measured: Baseline and Week 8
Hemiface Investigator's Global Assessment Grade Over Time
Acne severity was graded separately for each hemiface by a blinded evaluator using a five-category Investigator's Global Assessment scale ranging from 0 to 4, where 0 indicated clear skin and 4 indicated severe acne. Lower grades indicated lower acne severity.
Measured: Baseline, Week 4, Week 8, and Week 16
Participant Satisfaction With Each Hemiface
At Week 8, participants rated their satisfaction with each hemiface separately using an unvalidated numerical rating scale from 0 to 100. Higher scores indicated greater satisfaction.
Measured: Week 8
Incidence of Solicited Local and Systemic Adverse Events
Solicited local events included procedural pain, erythema, irritation, burning, dryness, blistering, and pigmentary alteration. Solicited systemic symptoms potentially associated with azithromycin included gastrointestinal symptoms, hypersensitivity reactions, palpitations, dizziness or syncope, and symptoms suggestive of hepatic dysfunction. Severity was classified as absent, mild, moderate, or severe.
Measured: From the first treatment through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start12 Oct 2025
- Primary completion10 Mar 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized within-participant split-face design. All participants received oral azithromycin. One hemiface was randomly allocated to adjunctive 308-nm excimer light, while the contralateral hemiface served as the oral-azithromycin-only control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Rageh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Rageh, Venus Research Center
- Investigators
- Rabie B Atallah, MD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777952
- Sponsor's protocol ID
- DFM-IRB-00012367-25-10-012
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data will not be shared because the original participant consent and institutional ethics framework did not prospectively authorize external sharing of participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Adjunctive 308-nm Excimer Light During Oral Azithromycin Therapy for Inflammatory Acne Vulgaris: A Randomized, Evaluator-Blinded, Split-Face Controlled Trial
- ClinicalTrials.gov ID
- NCT07777952
- Acronym / sponsor ID
- DFM-IRB-00012367-25-10-012
- Conditions
- Acne Vulgaris
- Keywords
- Inflammatory acne, 308-nm excimer light, Azithromycin, Phototherapy, Split-face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mahmoud RagehUniversity, hospital or other
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 21 Aug 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.
This randomized, evaluator-blinded, split-face study evaluated whether adjunctive lesion-directed 308-nm excimer light improves inflammatory acne outcomes during oral azithromycin therapy. All participants received oral azithromycin 500 mg three times weekly for 8 weeks. One randomly allocated hemiface additionally received 308-nm excimer light twice weekly for 8 weeks, while the contralateral hemiface served as the azithromycin-only control. Papule and pustule counts and hemiface Investigator's Global Assessment were assessed through Week 8. Investigator's Global Assessment was reassessed at Week 16 after an 8-week treatment-free follow-up. We hypothesized that the excimer-treated hemiface would demonstrate greater reduction in total inflammatory-lesion count by Week 8.
Detailed description
Participants with bilateral inflammatory acne received oral azithromycin 500 mg after meals three times weekly for 8 weeks. One hemiface was randomized by coin toss to receive adjunctive lesion-directed 308-nm excimer light twice weekly for 8 weeks; the contralateral hemiface received no irradiation. The primary outcome was the within-participant between-side difference in change from baseline to Week 8 in total inflammatory lesion count, defined as papules plus pustules. Hemiface IGA was assessed through Week 16, following an 8-week treatment-free period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized within-participant split-face design. All participants received oral azithromycin. One hemiface was randomly allocated to adjunctive 308-nm excimer light, while the contralateral hemiface served as the oral-azithromycin-only control.
| Arm | Type | Receives |
|---|---|---|
| Excimer Light Plus Oral Azithromycin Hemiface | Experimental | Device: 308-nm Excimer Light, Drug: AzithromycinOne randomly allocated hemiface received lesion-directed 308-nm excimer light twice weekly for 8 weeks in addition to the oral azithromycin received by all participants. |
| Oral Azithromycin Only Hemiface | Active comparator | Drug: AzithromycinThe contralateral hemiface received no excimer-light irradiation. All participants received oral azithromycin for 8 weeks. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female participants.
- age 15-35 years.
- Bilateral inflammatory acne involving both hemifaces, with clinically comparable baseline inflammatory involvement as assessed before randomization.
- No topical or systemic acne treatment during the preceding 8 weeks.
Key exclusion criteria (4 listed)
- Pregnancy.
- Photosensitivity disorders.
- Macrolide hypersensitivity.
- Concurrent isotretinoin use or isotretinoin use during the preceding 8 weeks.
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 |
|---|---|---|
| 308-nm Excimer LightMonochromatic 308-nm excimer light was delivered using the KN-5000C device. Irradiation was lesion-directed and administered twice weekly for 8 weeks, with at least 48 hours between sessions, for a planned total of 16 sessions. Treatment began at 0.15 J/cm² and was increased according to erythema response and device dose settings, up to a maximum of 0.65 J/cm². | Device | Excimer Light Plus Oral Azithromycin Hemiface |
| AzithromycinDescription: Oral azithromycin 500 mg was administered after meals three times weekly for 8 weeks, corresponding to 24 scheduled doses. | Drug | Excimer Light Plus Oral Azithromycin Hemiface, Oral Azithromycin Only Hemiface |
Primary outcome
Change From Baseline in Total Inflammatory-Lesion Count at Week 8
Time frame: Baseline and Week 8
Papules and pustules were counted separately for each hemiface by a blinded evaluator. Total inflammatory-lesion count was calculated as the sum of papules and pustules. Change was calculated as the baseline count minus the Week-8 count; positive values indicated improvement. The primary comparison was the within-participant difference in change between the excimer-treated and control hemifaces.
8 secondary outcomes
Change From Baseline in Papule Count at Week 8
Time frame: Baseline and Week 8
Change From Baseline in Pustule Count at Week 8
Time frame: Baseline and Week 8
Percentage Reduction in Total Inflammatory-Lesion Count at Week 8
Time frame: Baseline and Week 8
Proportion of Hemifaces With at Least 50% Reduction in Total Inflammatory-Lesion Count
Time frame: Baseline and Week 8
Proportion of Hemifaces With at Least 80% Reduction in Total Inflammatory-Lesion Count
Time frame: Baseline and Week 8
Hemiface Investigator's Global Assessment Grade Over Time
Time frame: Baseline, Week 4, Week 8, and Week 16
Participant Satisfaction With Each Hemiface
Time frame: Week 8
Incidence of Solicited Local and Systemic Adverse Events
Time frame: From the first treatment through Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Deidentified individual participant data will not be shared because the original participant consent and institutional ethics framework did not prospectively authorize external sharing of participant-level data.
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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. This study is not recruiting at the moment.
Rabie B Atallah, MD principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 308-nm Excimer Light and Azithromycin in people with Acne Vulgaris, run by Mahmoud Rageh 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Inflammatory-Lesion Count at Week 8 (time frame: Baseline and Week 8). 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 21 Aug 2026.