Skin Cancer
Conditions
Keywords
Mohs, scar, post excision, CO2 laser, laser, skin cancer, resurfacing
Brief 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.
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.
Interventions
DEVICELaser Treatment
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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MMSS for Scar Halves Treated | Day 0 and Day 14 | modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity | Day 0 and Day 14 | 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. |
| Quartile Scale | 24 weeks post-op | 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. |
Countries
United States
Participant flow
Pre-assignment details
Original protocol had 3 arms. Due to difficulty with enrollment, study did not perform a laser treatment at 9 weeks and the enrolled participants were all given the same intervention.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Fitzpatrick Skin Phototype I or II Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Participants With Fitzpatrick Skin Phototype I or II |
|---|---|
| Age, Continuous | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Scar length | 6.4 cm |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 20 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
MMSS for Scar Halves Treated
modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes
Time frame: Day 0 and Day 14
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Fitzpatrick Skin Phototype I or II | MMSS for Scar Halves Treated | Day 0 | 8.4 score on a scale |
| Participants With Fitzpatrick Skin Phototype I or II | MMSS for Scar Halves Treated | Day 14 | 8.7 score on a scale |
Secondary
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.
Time frame: Day 0 and Day 14
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Fitzpatrick Skin Phototype I or II | Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity | Fractal dimension (Fd) Day 0 | 1.778 units on a scale |
| Participants With Fitzpatrick Skin Phototype I or II | Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity | Fractal dimension (Fd) Day 14 | 1.781 units on a scale |
| Participants With Fitzpatrick Skin Phototype I or II | Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity | Lacunarity Day 0 | 0.368 units on a scale |
| Participants With Fitzpatrick Skin Phototype I or II | Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity | Lacunarity Day 14 | 0.345 units on a scale |
Secondary
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.
Time frame: 24 weeks post-op
Population: Data not collected