Photobiomodulation Therapy for Scar Quality After Facial Wound Closure

NCT07523204 | Active Not Recruiting

• 1 other identifier: PBMT-RCT-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Photobiomodulation therapy (PBMT); Traumatic facial wounds; Scar quality; Patient and Observer Scar Assessment Scale (POSAS)

Outcome Measures

Primary Outcomes (1)

• Scar Quality Assessed by POSAS

  Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), a validated scale that includes both observer-rated and patient-reported components. The POSAS consists of two subscales: * Observer Scale (6 items: vascularity, pigmentation, thickness, relief, pliability, and surface area) * Patient Scale (6 items: pain, pruritus, color, stiffness, thickness, and irregularity) Each item is scored on a 10-point scale ranging from 1 (normal skin) to 10 (worst imaginable scar), with a total score calculated by summing individual item scores. The total POSAS score ranges from 6 to 60 for each subscale, where lower scores indicate better scar quality and outcomes. Time Frame: 3 months and 12 months after completion of treatment.

  3 months and 12 months after completion of treatment

Study Arms (2)

Photobiomodulation Therapy (PBMT)

EXPERIMENTAL

Participants in this group will receive photobiomodulation therapy (PBMT) following suture removal. The treatment will be applied using a diode laser with standardized parameters including wavelength, power output, and energy density. PBMT will be administered over multiple sessions according to a predefined protocol to enhance scar quality and tissue healing.

Device: Photobiomodulation Therapy (PBMT)

Sham Laser (Control)

SHAM COMPARATOR

Participants in this group will receive a sham laser procedure following suture removal. The procedure will mimic the PBMT application in appearance and duration, but without delivering active laser energy. This approach is used to maintain participant blinding and serve as a control for comparison.

Device: Sham Photobiomodulation Therapy

Interventions

Photobiomodulation Therapy (PBMT) DEVICE

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.

Also known as: Low-Level Laser Therapy (LLLT)

Photobiomodulation Therapy (PBMT)

Sham Photobiomodulation Therapy DEVICE

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.

Sham Laser (Control)

Eligibility Criteria

• Age: 13 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients presenting with traumatic facial wounds requiring primary closure with sutures.
• Superficial to partial-thickness wounds located in the facial region (including infraorbital/periorbital, cheek, chin, forehead, or perioral areas).
• Wound length ranging from 3.5 to 10 cm.
• Patients willing to participate and comply with all treatment sessions and follow-up visits.
• Written informed consent obtained from adult participants or from parents/legal guardians for participants under 18 years of age.

You may not qualify if:

• Patients with uncontrolled systemic diseases that may impair wound healing (e.g., uncontrolled diabetes, immunocompromised conditions).
• Patients receiving medications known to affect wound healing (e.g., corticosteroids, immunosuppressive drugs).
• Presence of infected wounds at baseline.
• Patients with a history of keloid or hypertrophic scar formation.
• Pregnant or lactating women.
• Patients who are unable or unwilling to comply with the study protocol or follow-up schedule.

Sponsors & Collaborators

• Hani M. Al-Kufi: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, College of Dentistry, The Islamic University, Najaf, Iraq

Kufa, An Najaf, 54001, Iraq

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation through the use of a sham laser procedure identical in appearance to the active PBMT intervention. The outcomes assessor will also be blinded to treatment allocation to minimize assessment bias. The care provider administering the intervention cannot be blinded due to the nature of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer, College of Dentistry, Islamic University

Model Details: Participants will be randomly assigned to two parallel groups: a photobiomodulation therapy (PBMT) group and a sham control group following suture removal. PBMT will be delivered using standardized laser parameters. Outcomes will be assessed at predefined follow-up intervals to evaluate scar quality and treatment effectiveness.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: October 17, 2024
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)