NCT02130297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2019

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 19, 2021

Completed
Last Updated

April 19, 2021

Status Verified

March 1, 2021

Enrollment Period

4.9 years

First QC Date

April 29, 2014

Results QC Date

September 18, 2020

Last Update Submit

March 18, 2021

Conditions

Skin Cancer

Keywords

Mohsscarpost excisionCO2 laserlaserskin cancerresurfacing

Outcome Measures

Primary Outcomes (1)

  • MMSS for Scar Halves Treated

    modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes

    Day 0 and Day 14

Secondary Outcomes (2)

  • Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity

    Day 0 and Day 14

  • Quartile Scale

    24 weeks post-op

Study Arms (3)

Group 1 - day 1

ACTIVE COMPARATOR

Group 1 will receive laser therapy to half of the scar the day of the excision.

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.

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.

Device: Laser Treatment

Interventions

Laser TreatmentDEVICE

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.

Also known as: Lumenis UltraPulse Total FXTM fractionated CO2 laser
Group 1 - day 1Group 2 - day 14Group 3 - week 9

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Skin NeoplasmsCicatrix

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Limitations and Caveats

Single-center study with wounds limited to limbs of skin phototype I-II subjects.

Results Point of Contact

Title
Dr. Hooman Khorasani
Organization
Icahn School of Medicine at Mount Sinai
hooman.khorasani@mountsinai.org
347-574-8500

Study Officials

  • Hooman Khorasani, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 5, 2014

Study Start

May 1, 2014

Primary Completion

March 19, 2019

Study Completion

March 19, 2019

Last Updated

April 19, 2021

Results First Posted

April 19, 2021

Record last verified: 2021-03

Locations

US(1)