Skin CancerNCT02130297
Post Excision/Mohs Scar Laser Resurfacing
A study testing Laser Treatment in people with Skin Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated CO2 laser with the goal of decreasing the appearance and size of the scar. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Laser Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 19 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and aged >18 years at the time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Patients undergoing skin excisions of the face/trunk/extremities.
Who cannot join
- Inability to provide voluntary informed consent
- Use of laser or light based treatments to affected areas in past year
- Fitzpatrick Skin types 3-5
- Surgical lesions located on the central chest
- History of keloid formation
- History of Accutane in the last six months
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis Study
The purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated CO2 laser with the goal of decreasing the appearance and size of the scar.
Read the detailed description
The objective of this research is to determine, through a split scar study, that treating a post excision scar with a fractionated ablative CO2 laser improves both the texture and cosmetic appearance of the scar. An attempt will be made to determine the ideal timing for treating the excision scar as previous studies have ranged from treating the day of the excision up till 10 weeks post-excision. In order to evaluate the treated portion versus untreated portion of the scar, investigators and the subjects will use a quartile rating scale. In addition, punch biopsy samples will be taken to quantify the difference in collagen architecture 9 weeks after treatment with the laser.
There will be a total of 7 study visits to include the day of the excision and laser treatment if randomized to this group, post-op day number 14 for suture removal as well as laser therapy if the subject has been randomized to that treatment group, 4 weeks post-op, 9 weeks post-op and laser treatment for subjects randomized to this time frame for treatment, 12 weeks post-op, 17 weeks post-op and 24 weeks post-op. Each visit will last approximately 30-45 minutes each in which clinical photos of the surgical scar will be taken and any wound care or side effects of the laser therapy or surgery will be addressed. Healing and scar appearance will be reviewed and rated at each of the six postsurgical visits.
- Conditions
- Skin Cancer
- Being tested
- Laser Treatment
- Keywords
- Mohs, scar, post excision, CO2 laser, laser, skin cancer, resurfacing
- Medical subject headings
- Skin Neoplasms, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TreatmentDevice
Also called Lumenis UltraPulse Total FXTM fractionated CO2 laser
The subject will receive ablative fractional resurfacing with the Deep and Active FXTM platforms of the Lumenis Ultrapulse CO2 laser. The settings for treatment of scars on the face with the Deep platform will be 15% coverage, 15mJ at 150 Hz and 15% coverage, 12.5 mJ at 150 Hz for off the face. The Active platform settings will be 90 mJ with a density of 3 for the face and 70 mJ and a density of 2 for off the face. The DeepFXTM platform will be applied to the scar prior to the ActiveFX TM platform. Half of the excision scar will be treated with the appropriate settings and half will go untreated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - day 1 | Active comparator | Group 1 will receive laser therapy to half of the scar the day of the excision. Receives: Device: Laser Treatment |
| Group 2 - day 14 | Active comparator | Group 2 will receive laser therapy at the time of suture removal or post-operative day 14. Receives: Device: Laser Treatment |
| Group 3 - week 9 | Active comparator | Group 3 will receive laser treatment to half the scar at the 9 week postop visit. Receives: Device: Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSS for Scar Halves Treated
modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes
Measured: Day 0 and Day 14
Secondary outcomes (2)
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity
Fd indicates scar tissue density - a measure of how completely an object fills space and increases in value with increasing structural density. It has a value between 1 and 2: a minimum value of 1 corresponds to a straight line filling the space, and a maximum value of 2 corresponds to an object completely occupying the entire space.
Lacunarity describes the characteristics of fractals of the same dimension with different texture appearances and indicates scar tissue architecture (homogeneous vs. heterogeneous) - a measure of the nonuniformity (heterogeneity) of a structure or the degree of structural variance within an object. L has a value between 0 and 1, where a minimum value of 0 corresponds to an absolute homogeneous object.
Measured: Day 0 and Day 14
Quartile Scale
Comparison of scars using quartile scale: 0 indicates no difference, 1 indicates a 1-25% difference or "mild" difference, 2 indicates a 26-50% or moderate difference, 3 indicates a 51-75% or significant improvement and 4 indicates a 76-100% difference or very significant.
Measured: 24 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startMay 2014
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hooman Khorasani, Icahn School of Medicine at Mount Sinai
- Investigators
- Hooman Khorasani, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130297
- Sponsor's protocol ID
- GCO 14-0387
- Status last verified
- Mar 2021
- First submitted
- 29 Apr 2014
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis Study
- ClinicalTrials.gov ID
- NCT02130297
- Acronym / sponsor ID
- GCO 14-0387
- Conditions
- Skin Cancer
- Keywords
- Mohs, scar, post excision, CO2 laser, laser, skin cancer, resurfacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated CO2 laser with the goal of decreasing the appearance and size of the scar.
Detailed description
The objective of this research is to determine, through a split scar study, that treating a post excision scar with a fractionated ablative CO2 laser improves both the texture and cosmetic appearance of the scar. An attempt will be made to determine the ideal timing for treating the excision scar as previous studies have ranged from treating the day of the excision up till 10 weeks post-excision. In order to evaluate the treated portion versus untreated portion of the scar, investigators and the subjects will use a quartile rating scale. In addition, punch biopsy samples will be taken to quantify the difference in collagen architecture 9 weeks after treatment with the laser.
There will be a total of 7 study visits to include the day of the excision and laser treatment if randomized to this group, post-op day number 14 for suture removal as well as laser therapy if the subject has been randomized to that treatment group, 4 weeks post-op, 9 weeks post-op and laser treatment for subjects randomized to this time frame for treatment, 12 weeks post-op, 17 weeks post-op and 24 weeks post-op. Each visit will last approximately 30-45 minutes each in which clinical photos of the surgical scar will be taken and any wound care or side effects of the laser therapy or surgery will be addressed. Healing and scar appearance will be reviewed and rated at each of the six postsurgical visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - day 1 | Active comparator | Device: Laser TreatmentGroup 1 will receive laser therapy to half of the scar the day of the excision. |
| Group 2 - day 14 | Active comparator | Device: Laser TreatmentGroup 2 will receive laser therapy at the time of suture removal or post-operative day 14. |
| Group 3 - week 9 | Active comparator | Device: Laser TreatmentGroup 3 will receive laser treatment to half the scar at the 9 week postop visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and aged >18 years at the time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Patients undergoing skin excisions of the face/trunk/extremities.
Key exclusion criteria (6 listed)
- Inability to provide voluntary informed consent
- Use of laser or light based treatments to affected areas in past year
- Fitzpatrick Skin types 3-5
- Surgical lesions located on the central chest
- History of keloid formation
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: Lumenis UltraPulse Total FXTM fractionated CO2 laserThe subject will receive ablative fractional resurfacing with the Deep and Active FXTM platforms of the Lumenis Ultrapulse CO2 laser. The settings for treatment of scars on the face with the Deep platform will be 15% coverage, 15mJ at 150 Hz and 15% coverage, 12.5 mJ at 150 Hz for off the face. The Active platform settings will be 90 mJ with a density of 3 for the face and 70 mJ and a density of 2 for off the face. The DeepFXTM platform will be applied to the scar prior to the ActiveFX TM platform. Half of the excision scar will be treated with the appropriate settings and half will go untreated. | Device | Group 1 - day 1, Group 2 - day 14, Group 3 - week 9 |
Primary outcome
MMSS for Scar Halves Treated
Time frame: Day 0 and Day 14
modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes
2 secondary outcomes
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity
Time frame: Day 0 and Day 14
Quartile Scale
Time frame: 24 weeks post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hooman Khorasani, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Skin Cancer, run by Icahn School of Medicine at Mount Sinai 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 4 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: finished, as of the sponsor's last update on 19 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MMSS for Scar Halves Treated (time frame: Day 0 and Day 14). 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 19 Apr 2021.