Post Excision/Mohs Scar Laser Resurfacing
Conditions
Skin Cancer
Conditions: official terms
Skin Neoplasms
Conditions: Keywords
Mohs, scar, post excision, CO2 laser, laser, skin cancer, resurfacing
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: Laser Treatment
Type: Device
Overall Status
Recruiting
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 (2-4). 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 10 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Status: Recruiting
Start Date
May 2014
Completion Date
December 2014
Sponsors
Icahn School of Medicine at Mount Sinai
Source
Icahn School of Medicine at Mount Sinai
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page