Traumatic Facial WoundsPBMT-SCARNCT07523204
Photobiomodulation Therapy for Scar Quality After Facial Wound Closure
A study testing Photobiomodulation Therapy (PBMT) in people with Traumatic Facial Wounds, run by Hani M. Al-Kufi at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 47 years
- Conditions the study is for
- Traumatic Facial Wounds
- What is being tested?
- Photobiomodulation Therapy (PBMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIraq
- Study dates
- 17 Oct 2024to 20 Oct 2026
- Phase
- Interventional
- 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 13 to 47 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Department of Oral and Maxillofacial Surgery, College of Dentistry, The Islamic University, Najaf, Iraq
Kufa, Najaf, 54001
About this study
Official title: Effect of Photobiomodulation Therapy (PBMT) on Scar Quality Following Traumatic Facial Wound Closure: A Prospective Pilot Randomized Controlled Trial
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.
Read the detailed description
This prospective pilot randomized controlled clinical trial aims to investigate the effect of photobiomodulation therapy (PBMT) on scar quality following traumatic facial wound closure. Traumatic facial wounds represent a common clinical challenge in oral and maxillofacial surgery, often leading to scar formation with aesthetic and psychological consequences. Despite advances in wound management, optimizing scar quality remains a significant concern.
Photobiomodulation therapy (PBMT) has gained increasing attention due to its potential to promote tissue regeneration, enhance collagen organization, modulate inflammatory responses, and accelerate the healing process. In this study, eligible patients presenting with traumatic facial wounds requiring primary closure will be included. All wounds will be managed using standardized surgical protocols, including layered suturing techniques.
Following suture removal, participants will be randomly allocated into two groups: an intervention group receiving PBMT and a control group receiving sham treatment. PBMT will be applied using a diode laser with predefined parameters, including wavelength, power output, irradiation time, and energy density, ensuring consistency across all treatment sessions. The therapy will be administered over multiple sessions according to a standardized treatment protocol.
Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), a validated tool that assesses multiple scar characteristics from both clinician and patient perspectives. Assessments will be performed at predefined follow-up intervals to monitor scar maturation and overall outcomes.
The primary outcome of this study is the improvement in scar quality as measured by POSAS scores. This study is designed as a pilot trial to generate preliminary data that may support the development of larger randomized controlled trials in the future. The results are expected to contribute to the growing body of evidence regarding the clinical applications of PBMT in soft tissue healing and scar management.
- Conditions
- Traumatic Facial Wounds
- Being tested
- Photobiomodulation Therapy (PBMT), Sham Photobiomodulation Therapy
- Keywords
- Photobiomodulation therapy (PBMT), Traumatic facial wounds, Scar quality, Patient and Observer Scar Assessment Scale (POSAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation Therapy (PBMT)Device
Also called Low-Level Laser Therapy (LLLT)
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.
Sham Photobiomodulation TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months and 12 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start17 Oct 2024
- Primary completion7 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Facial WoundsStudies 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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hani M. Al-Kufi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hani M. Al-Kufi, Islamic University of Najaf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523204
- Sponsor's protocol ID
- PBMT-RCT-2024
- Acronym
- PBMT-SCAR
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 15 Apr 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation Therapy (PBMT) on Scar Quality Following Traumatic Facial Wound Closure: A Prospective Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07523204
- Acronym / sponsor ID
- PBMT-SCAR / PBMT-RCT-2024
- Conditions
- Traumatic Facial Wounds
- Keywords
- Photobiomodulation therapy (PBMT), Traumatic facial wounds, Scar quality, Patient and Observer Scar Assessment Scale (POSAS)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hani M. Al-KufiUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 7 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 13 Apr 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 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.
Detailed description
This prospective pilot randomized controlled clinical trial aims to investigate the effect of photobiomodulation therapy (PBMT) on scar quality following traumatic facial wound closure. Traumatic facial wounds represent a common clinical challenge in oral and maxillofacial surgery, often leading to scar formation with aesthetic and psychological consequences. Despite advances in wound management, optimizing scar quality remains a significant concern.
Photobiomodulation therapy (PBMT) has gained increasing attention due to its potential to promote tissue regeneration, enhance collagen organization, modulate inflammatory responses, and accelerate the healing process. In this study, eligible patients presenting with traumatic facial wounds requiring primary closure will be included. All wounds will be managed using standardized surgical protocols, including layered suturing techniques.
Following suture removal, participants will be randomly allocated into two groups: an intervention group receiving PBMT and a control group receiving sham treatment. PBMT will be applied using a diode laser with predefined parameters, including wavelength, power output, irradiation time, and energy density, ensuring consistency across all treatment sessions. The therapy will be administered over multiple sessions according to a standardized treatment protocol.
Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), a validated tool that assesses multiple scar characteristics from both clinician and patient perspectives. Assessments will be performed at predefined follow-up intervals to monitor scar maturation and overall outcomes.
The primary outcome of this study is the improvement in scar quality as measured by POSAS scores. This study is designed as a pilot trial to generate preliminary data that may support the development of larger randomized controlled trials in the future. The results are expected to contribute to the growing body of evidence regarding the clinical applications of PBMT in soft tissue healing and scar management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Therapy (PBMT) | Experimental | Device: Photobiomodulation Therapy (PBMT)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. |
| Sham Laser (Control) | Sham comparator | Device: Sham Photobiomodulation TherapyParticipants 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. |
Who may qualify
- Ages
- 13 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Photobiomodulation Therapy (PBMT)Also: Low-Level Laser Therapy (LLLT)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 | Photobiomodulation Therapy (PBMT) |
| Sham Photobiomodulation TherapyA 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. | Device | Sham Laser (Control) |
Primary outcome
Scar Quality Assessed by POSAS
Time frame: 3 months and 12 months after completion of treatment
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.
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 15 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation Therapy (PBMT) in people with Traumatic Facial Wounds, run by Hani M. Al-Kufi at 1 site in Iraq.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 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 Iraq. 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. Some participants in this study may receive a placebo. 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?
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?
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?
Scar Quality Assessed by POSAS (time frame: 3 months and 12 months after completion of treatment). 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 15 Apr 2026.