ScarNCT03057964
PDL and Fractional Photothermolysis for Postsurgical Scars
A study testing PDL (Pulsed Dye Laser) and Fractional Photothermolysis Laser in people with Scar, run by Northwestern University at 1 site in United States.
Trial summary
This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- PDL (Pulsed Dye Laser) and Fractional Photothermolysis Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to Dec 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females ≥ 18 years old
- Fitzpatrick skin types I-VI
- Subjects are in good health as judged by the investigator.
- Subjects who have received dermatologic surgery procedure of the trunk or extremities closed with complex primary closure with subcuticular running suture removed at 2-3 weeks.
- Subjects applying topical retinoids, must discontinue one week prior to treatment.
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Who cannot join
- History of recurrent facial or labial herpes simplex infection
- Subjects applying topical retinoids, must discontinue one week prior to treatment.
- Subjects with a history of hypertrophic scars or keloids
- Pregnant or breast feeding
- Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- Subjects who are unable to understand the protocol or give informed consent.
- Subjects who in the opinion of the investigator are likely to have exaggerated scarring with laser treatments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars
This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis.
Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design.
Read more
The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
This study is a pilot study designed to determine feasibility of this procedure.
- Conditions
- Scar
- Being tested
- PDL (Pulsed Dye Laser), Fractional Photothermolysis Laser
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDL (Pulsed Dye Laser)Device
Also called Pulsed Dye Laser
For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis.
Fractional Photothermolysis LaserDevice
Also called Fraxel Laser
For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis.
| Study group | Role | What they receive |
|---|---|---|
| PDL (Pulsed Dye Laser) and Fractional Photothermolysis | Experimental | Not described Receives: Device: PDL (Pulsed Dye Laser); Device: Fractional Photothermolysis Laser |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score of Patient and Observer Scar Assessment Scale (POSAS)
The POSAS is a series of questions about the scar with a scale from 1 to 10 with 1 as "not at all" or "normal skin" and 10 as "very much so" or "very different".
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Mar 2017
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057964
- Sponsor's protocol ID
- STU00204024
- Status last verified
- Jun 2026
- First submitted
- 9 Feb 2017
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kang BY, Ibrahim SA, Weil A, Reynolds KA, Johnson T, Wilson S, Lee MH, Kim JYS, Dirr MA, Poon E, Alam M. Treatment of Surgical Scars With Combination Pulsed Dye and Fractional Nonablative Laser: A Randomized Controlled Trial. Ann Surg. 2022 Dec 1;276(6):975-980. doi: 10.1097/SLA.0000000000005377. Epub 2022 Jan 25.
PubMed 35081564
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars
- ClinicalTrials.gov ID
- NCT03057964
- Acronym / sponsor ID
- STU00204024
- Conditions
- Scar
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Feb 2017 (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 is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis.
Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design.
The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
This study is a pilot study designed to determine feasibility of this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDL (Pulsed Dye Laser) and Fractional Photothermolysis | Experimental | Device: PDL (Pulsed Dye Laser), Device: Fractional Photothermolysis Laser |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females ≥ 18 years old
- Fitzpatrick skin types I-VI
- Subjects are in good health as judged by the investigator.
- Subjects who have received dermatologic surgery procedure of the trunk or extremities closed with complex primary closure with subcuticular running suture removed at 2-3 weeks.
- Subjects applying topical retinoids, must discontinue one week prior to treatment.
Key exclusion criteria (7 listed)
- History of recurrent facial or labial herpes simplex infection
- Subjects applying topical retinoids, must discontinue one week prior to treatment.
- Subjects with a history of hypertrophic scars or keloids
- Pregnant or breast feeding
- Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
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 |
|---|---|---|
| PDL (Pulsed Dye Laser)Also: Pulsed Dye LaserFor those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis. | Device | PDL (Pulsed Dye Laser) and Fractional Photothermolysis |
| Fractional Photothermolysis LaserAlso: Fraxel LaserFor those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis. | Device | PDL (Pulsed Dye Laser) and Fractional Photothermolysis |
Primary outcome
Change in score of Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Baseline and 6 Months
The POSAS is a series of questions about the scar with a scale from 1 to 10 with 1 as "not at all" or "normal skin" and 10 as "very much so" or "very different".
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 1 Jul 2026.
- Derived from this study: PubMed 35081564Kang BY, Ibrahim SA, Weil A, Reynolds KA, Johnson T, Wilson S, Lee MH, Kim JYS, Dirr MA, Poon E, Alam M. Treatment of Surgical Scars With Combination Pulsed Dye and Fractional Nonablative Laser: A Randomized Controlled Trial. Ann Surg. 2022 Dec 1;276(6):975-980. doi: 10.1097/SLA.0000000000005377. Epub 2022 Jan 25.
- 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.
Murad Alam, MD principal investigator
Northwestern 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 PDL (Pulsed Dye Laser) and Fractional Photothermolysis Laser in people with Scar, run by Northwestern University at 1 site in United States.
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 6 inclusion and 7 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 1 Jul 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 United States. 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?
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?
Change in score of Patient and Observer Scar Assessment Scale (POSAS) (time frame: Baseline and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03057964, which also lists 1 linked publication.
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 1 Jul 2026.