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Completed

NCT Number: NCT07777952

Adjunctive 308-nm Excimer Light With Oral Azithromycin for Inflammatory Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University Hospital

Damietta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Pregnancy.
  • Photosensitivity disorders.
  • Macrolide hypersensitivity.
  • Concurrent isotretinoin use or isotretinoin use during the preceding 8 weeks.

Treatment and study plan

308-nm Excimer Light

Device

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.

Azithromycin

Drug

Description: Oral azithromycin 500 mg was administered after meals three times weekly for 8 weeks, corresponding to 24 scheduled doses.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline in Papule Count at Week 8

    Time frame: Baseline and 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.

  2. Change From Baseline in Pustule Count at Week 8

    Time frame: Baseline and 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.

  3. Percentage Reduction in Total Inflammatory-Lesion Count at Week 8

    Time frame: Baseline and 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.

  4. Proportion of Hemifaces With at Least 50% Reduction in Total Inflammatory-Lesion Count

    Time frame: Baseline and Week 8

    A responder was defined as a hemiface achieving at least a 50% reduction in total inflammatory-lesion count from baseline to Week 8.

  5. Proportion of Hemifaces With at Least 80% Reduction in Total Inflammatory-Lesion Count

    Time frame: Baseline and Week 8

    A responder was defined as a hemiface achieving at least an 80% reduction in total inflammatory-lesion count from baseline to Week 8.

  6. Hemiface Investigator's Global Assessment Grade Over Time

    Time frame: Baseline, Week 4, Week 8, and Week 16

    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.

  7. Participant Satisfaction With Each Hemiface

    Time frame: Week 8

    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.

  8. Incidence of Solicited Local and Systemic Adverse Events

    Time frame: From the first treatment through Week 16

    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.

Sponsors and collaborators

Lead sponsor

Mahmoud Rageh

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 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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