Post Surgical ScarsNCT00685243
Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
A study testing Laser treatment in people with Post Surgical Scars, run by Henry Ford Health System at 1 site in United States.
Trial summary
1. Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes. 2. Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which is utilized for the treatment of the erythematous and telangiectasia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Scars
- What is being tested?
- Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old;
- Be otherwise healthy;
- Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
- Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
- Agree to follow and undergo all study-related procedures.
Who cannot join
- Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
- The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
- We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Henry Ford Medical Center, 6530 Farmington Rd
West Bloomfield, Michigan, 48322
About this study
- Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes.
- Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which is utilized for the treatment of the erythematous and telangiectasia component of surgical scars.
- Comparison of the outcome of the half of the surgical scar treated with Fraxel SR laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser.
Read the detailed description
RATIONALE FOR THE PROJECT
Surgical scars are a challenging condition to treat. The aesthetic outcome of surgical scars is of great importance to patients and physicians after reconstructive surgery. The current approaches for the treatment of surgical scars range from non-invasive approaches to aggressive treatments with re-excision or ablative resurfacing lasers. Fractional photothemolysis is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars.
Fractional photothemolysis (Fraxel SR laser, Reliant technologies, Inc) is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars. Fractionated resurfacing, with its significant proven efficacy in improving textural and pigmenatary abnormalities with a benign side effect profile, represents a promising novel treatment for surgical scars.
Aim:
Comparison of the outcome of the half of the surgical scar treated with Fraxel SR (Reliant Technologies, Inc.) laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser
SIGNIFICANCE:
The cosmetic outcome of surgical scars is of paramount importance to surgeons and patients treated with both cosmetic and reconstructive surgery. It is impossible for surgeons to predict the wound healing properties of individual patients and particular anatomic sites and thus, there is little certainty that can be offered to patients about the cosmetic outcome of their surgical scars.
SUBJECTS IN THE PROJECT:
Inclusion Criteria:
For inclusion, the subject must:
- Be at least 18 years old;
- Be otherwise healthy;
- Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
- Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
- Agree to follow and undergo all study-related procedures.
Exclusion criteria:
- Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
- The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
- We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
PROJECT DESIGN AND PROCOTOL:
- A comparison trial of surgical scars treated with Fraxel SR Laser (Reliant Technologies, Inc.) versus V-Beam Pulse Dye Laser (Candela Corporation) in 15 patients who underwent Mohs surgery and resultant cosmetic surgical reconstruction at Henry Ford Health System Department of Dermatology.
- At a minimum of 2 months post surgical reconstruction, patients will be eligible for inclusion in this research study. During each 2 weeks of the study, one side of the surgical scar will be treated with Fraxel SR (Reliant Technologies, Inc.) and the other half will be treated with the V-Beam Pulse Dye Laser (Candela Corporation) for aesthetic improvement of the scar
- Conditions
- Post Surgical Scars
- Being tested
- Laser treatment
- Keywords
- Fraxel, Pulsed dye laser, Surgical scars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentProcedure or surgery
Also called -Fraxel SR Laser (Reliant Technologies, Inc.), -V-Beam Pulse Dye laser (Candela Corporation)
Fraxel and pulsed dye laser
| Study group | Role | What they receive |
|---|---|---|
| Fraxel | Active comparator | Fraxel laser treatment Receives: Procedure: Laser treatment |
| PDL | Active comparator | Pulsed dye laser treatment Receives: Procedure: Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cosmetic appearance, relative to adjacent skin and side effects.
Measured: 6 months
Secondary outcomes (1)
skin matches surrounding skin, no scar formation visible, skin pigmentation and/or texture of scarred region is markedly different from surrounding skin).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Surgical ScarsStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Cosmetic Surgery
- Responsible party
- Principal investigator, David M. Ozog, Henry Ford Health System
- Investigators
- David Kouba, MD, PhD, Principal investigator, Department of Dermatology, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685243
- Sponsor's protocol ID
- IRB4812
- Status last verified
- Apr 2023
- First submitted
- 23 May 2008
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Alster TS. Improvement of erythematous and hypertrophic scars by the 585-nm flashlamp-pumped pulsed dye laser. Ann Plast Surg. 1994 Feb;32(2):186-90. doi: 10.1097/00000637-199402000-00015.
PubMed 8192370Behroozan DS, Goldberg LH, Dai T, Geronemus RG, Friedman PM. Fractional photothermolysis for the treatment of surgical scars: a case report. J Cosmet Laser Ther. 2006 Apr;8(1):35-8. doi: 10.1080/14764170600607251.
PubMed 16581684
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Surgical Scars With Fractional Photothemolysis Versus Pulse Dye Laser
- ClinicalTrials.gov ID
- NCT00685243
- Acronym / sponsor ID
- IRB4812
- Conditions
- Post Surgical Scars
- Keywords
- Fraxel, Pulsed dye laser, Surgical scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- American Academy of Cosmetic Surgery
- Study start
- Jan 2008 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 May 2008 (estimated)
- 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.
- Evaluate the efficacy of the Fraxel SR laser to improve the cosmetic appearance of surgical scars, both in terms of pigmentary and textural changes.
- Evaluate the efficacy of the V-Beam Pulse Dye laser, a standard non-ablative laser which is utilized for the treatment of the erythematous and telangiectasia component of surgical scars.
- Comparison of the outcome of the half of the surgical scar treated with Fraxel SR laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser.
Detailed description
RATIONALE FOR THE PROJECT
Surgical scars are a challenging condition to treat. The aesthetic outcome of surgical scars is of great importance to patients and physicians after reconstructive surgery. The current approaches for the treatment of surgical scars range from non-invasive approaches to aggressive treatments with re-excision or ablative resurfacing lasers. Fractional photothemolysis is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars.
Fractional photothemolysis (Fraxel SR laser, Reliant technologies, Inc) is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars. Fractionated resurfacing, with its significant proven efficacy in improving textural and pigmenatary abnormalities with a benign side effect profile, represents a promising novel treatment for surgical scars.
Aim:
Comparison of the outcome of the half of the surgical scar treated with Fraxel SR (Reliant Technologies, Inc.) laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser
SIGNIFICANCE:
The cosmetic outcome of surgical scars is of paramount importance to surgeons and patients treated with both cosmetic and reconstructive surgery. It is impossible for surgeons to predict the wound healing properties of individual patients and particular anatomic sites and thus, there is little certainty that can be offered to patients about the cosmetic outcome of their surgical scars.
SUBJECTS IN THE PROJECT:
Inclusion Criteria:
For inclusion, the subject must:
- Be at least 18 years old;
- Be otherwise healthy;
- Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
- Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
- Agree to follow and undergo all study-related procedures.
Exclusion criteria:
- Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
- The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
- We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
PROJECT DESIGN AND PROCOTOL:
- A comparison trial of surgical scars treated with Fraxel SR Laser (Reliant Technologies, Inc.) versus V-Beam Pulse Dye Laser (Candela Corporation) in 15 patients who underwent Mohs surgery and resultant cosmetic surgical reconstruction at Henry Ford Health System Department of Dermatology.
- At a minimum of 2 months post surgical reconstruction, patients will be eligible for inclusion in this research study. During each 2 weeks of the study, one side of the surgical scar will be treated with Fraxel SR (Reliant Technologies, Inc.) and the other half will be treated with the V-Beam Pulse Dye Laser (Candela Corporation) for aesthetic improvement of the scar
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fraxel | Active comparator | Procedure: Laser treatmentFraxel laser treatment |
| PDL | Active comparator | Procedure: Laser treatmentPulsed dye laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years old;
- Be otherwise healthy;
- Be treated by Dr. Kouba for a skin cancer surgery or plastic surgery procedure
- Agree to attend up 6 sessions post Mohs surgery (2-4 laser treatment sessions and 2 follow-up visits post-laser)
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
Key exclusion criteria (3 listed)
- Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
- The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
- We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
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 |
|---|---|---|
| Laser treatmentAlso: -Fraxel SR Laser (Reliant Technologies, Inc.), -V-Beam Pulse Dye laser (Candela Corporation)Fraxel and pulsed dye laser | Procedure or surgery | Fraxel, PDL |
Primary outcome
Overall cosmetic appearance, relative to adjacent skin and side effects.
Time frame: 6 months
1 secondary outcome
skin matches surrounding skin, no scar formation visible, skin pigmentation and/or texture of scarred region is markedly different from surrounding skin).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Background: PubMed 8192370Alster TS. Improvement of erythematous and hypertrophic scars by the 585-nm flashlamp-pumped pulsed dye laser. Ann Plast Surg. 1994 Feb;32(2):186-90. doi: 10.1097/00000637-199402000-00015.
- Background: PubMed 16581684Behroozan DS, Goldberg LH, Dai T, Geronemus RG, Friedman PM. Fractional photothermolysis for the treatment of surgical scars: a case report. J Cosmet Laser Ther. 2006 Apr;8(1):35-8. doi: 10.1080/14764170600607251.
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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.
David Kouba, MD, PhD principal investigator
Department of Dermatology, Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Post Surgical Scars, run by Henry Ford Health System 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 3 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: finished, as of the sponsor's last update on 10 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall cosmetic appearance, relative to adjacent skin and side effects. (time frame: 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 NCT00685243, which also lists 2 linked publications.
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 10 Apr 2023.