Clinical trial NCT02130297: Post Excision/Mohs Scar Laser Resurfacing
Official title: Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: Mohs
scar
post excision
CO2 laser
laser
skin cancer
resurfacing
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: MMSS for Scar Halves Treated
timeFrame: Day 0 and Day 14
Secondary outcomes:
measure: Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity
timeFrame: Day 0 and Day 14
measure: Quartile Scale
timeFrame: 24 weeks post-op
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Hooman Khorasani, MD
role: PRINCIPAL_INVESTIGATOR
References: