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Photobiomodulation Therapy for Scar Quality After Facial Wound Closure

NCT07523204 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-15

No results posted yet for this study

Summary

This study is a prospective pilot randomized controlled trial designed to evaluate the effect of photobiomodulation therapy (PBMT) on scar quality following traumatic facial wound closure. Traumatic facial wounds often result in aesthetically and functionally significant scars, which may negatively affect patients' quality of life. PBMT has been proposed as a non-invasive adjunctive therapy that may enhance tissue repair, reduce inflammation, and improve scar outcomes.

In this study, patients with traumatic facial wounds undergoing primary closure will be randomly assigned to receive either PBMT or sham treatment following suture removal. Scar quality will be assessed using validated clinical scales over a defined follow-up period. The findings of this study aim to provide clinical evidence regarding the effectiveness of PBMT in improving scar appearance and overall healing outcomes.

Conditions

  • Traumatic Facial Wounds

Interventions

DEVICE

Photobiomodulation Therapy (PBMT)

Photobiomodulation therapy (PBMT) will be administered using a 940 nm diode laser (EPIC X, Biolase Inc., Irvine, CA, USA). The laser will operate in continuous wave (CW) mode with a power output of 2 W. The beam diameter will be approximately 3 cm, corresponding to a spot size of about 7.07 cm and an irradiance of approximately 0.3 W/cm². Each irradiation point will be exposed for 20 seconds, delivering an energy density of approximately 5.6 J/cm. PBMT sessions will be performed three times per week for a total of 10 sessions. Laser irradiation will be delivered using a specialized handpiece in a defocused, non-contact mode to ensure uniform energy distribution across the treatment area.

DEVICE

Sham Photobiomodulation Therapy

A sham photobiomodulation therapy procedure will be performed using the same 940 nm diode laser device (EPIC X, Biolase Inc., Irvine, CA, USA) without emitting active laser energy. The laser handpiece will be applied in a defocused, non-contact manner over the wound area following suture removal, with the same application time (20 seconds per point) and session frequency (three times per week for a total of 10 sessions) as the active treatment group. This approach is used to maintain participant blinding while ensuring no therapeutic laser energy is delivered.

Sponsors & Collaborators

  • Hani M. Al-Kufi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
47 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-17
Primary Completion
2026-10-07
Completion
2026-10-20

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523204 on ClinicalTrials.gov