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Trial record 80 of 537 for:    "Skin cancer"

Post Excision/Mohs Scar Laser Resurfacing

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ClinicalTrials.gov Identifier: NCT02130297
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hooman Khorasani, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Skin Cancer Device: Laser Treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis Study
Study Start Date : May 2014
Actual Primary Completion Date : March 19, 2019
Actual Study Completion Date : March 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: Group 1 - day 1
Group 1 will receive laser therapy to half of the scar the day of the excision.
Device: Laser 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.
Other Name: Lumenis UltraPulse Total FXTM fractionated CO2 laser

Active Comparator: Group 2 - day 10
Group 2 will receive laser therapy at the time of suture removal or post-operative day 10.
Device: Laser 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.
Other Name: Lumenis UltraPulse Total FXTM fractionated CO2 laser

Active Comparator: Group 3 - week 9
Group 3 will receive laser treatment to half the scar at the 9 week postop visit.
Device: Laser 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.
Other Name: Lumenis UltraPulse Total FXTM fractionated CO2 laser




Primary Outcome Measures :
  1. Comparison of scars using quartile scale [ Time Frame: 24 weeks post-op ]

Secondary Outcome Measures :
  1. Comparison of scar ultrastructure using the Scar index [ Time Frame: 24 weeks post-op ]
    Biopsies of the treated and untreated portions of the scar will be examined and compared by histology. To evaluate this ultrastructure, confocal microscopy using fractional dimension and lacunarity analysis will be used. Further scar analysis will be performed by H&E staining photographs captured on an Olympus BX51 microscope (Olympus America Inc. Center Valley, PA) equipped with MicroFire 2.2 digital camera (Optronics, Goleta, CA) using PictureFrame 2.0 software at 40X magnification. Image analysis will then be performed using NIH's shareware program, ImageJ and the Scar index will be determined.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130297


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Hooman Khorasani, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Hooman Khorasani, Clinical Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02130297     History of Changes
Other Study ID Numbers: GCO 14-0387
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

Keywords provided by Hooman Khorasani, Icahn School of Medicine at Mount Sinai:
Mohs
scar
post excision
CO2 laser
laser
skin cancer
resurfacing

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases