NCT02898350

Brief Summary

Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

September 8, 2016

Last Update Submit

September 13, 2016

Conditions

Scars

Outcome Measures

Primary Outcomes (1)

  • Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline

    Blinded review of 7-point Global Evaluation Response (GER) scale

    Baseline, 3 months after final treatment

Secondary Outcomes (1)

  • Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline

    Baseline, 3 months after final treatment

Other Outcomes (1)

  • Number and severity of adverse events

    Baseline and up to 3 months after treatment

Study Arms (4)

Pulsed Dye Laser treatment

ACTIVE COMPARATOR

Pulsed Dye Laser treatment after suture removal (3 sessions)

Device: Pulsed dye laser treatment

CO2 laser treatment

ACTIVE COMPARATOR

CO2 laser (3 treatment sessions) after suture removal

Device: CO2 laser treatment

Combined PDL and CO2 Laser treatment

ACTIVE COMPARATOR

Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal

Device: Combined PDL and CO2 laser treatment

Split PDL and CO2 Laser treatment

ACTIVE COMPARATOR

Half of the scar was not treated and served as a control, while the other half was treated with CO2 ablative fractional resurfacing immediately after surgery, in addition to the three combined PDL and CO2 treatment sessions after suture removal

Device: Split PDL and CO2 Laser treatment

Interventions

Pulsed dye laser treatmentDEVICE

Scar minimization with Pulsed dye laser treatment on suture removal day

Also known as: Vbeam, Vbeam Perfecta, PDL
Pulsed Dye Laser treatment
CO2 laser treatmentDEVICE

Scar minimization with CO2 laser treatment on suture removal day

Also known as: CO2RE, CORE
CO2 laser treatment
Combined PDL and CO2 laser treatmentDEVICE

Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day

Also known as: Vbeam, Vbeam Perfecta, CO2RE, CORE
Combined PDL and CO2 Laser treatment
Split PDL and CO2 Laser treatmentDEVICE

Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day

Split PDL and CO2 Laser treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Comprehension of, and willingness to sign, the Informed Consent Form.
  • Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm.
  • Be a healthy male or female of at least 18 years old.
  • Fitzpatrick skin type I-V.
  • Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions.
  • Non pregnant and/or breast feeding, if applicable.
  • Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.
  • Agree to follow and undergo all study-related procedures.
  • Use of daily use of sunblock SPF 30 or higher for duration of the study.

You may not qualify if:

  • Pregnant and/or breastfeeding.
  • Fitzpatrick skin type VI.
  • Prior treatment for the surgical scar to be treated in this study.
  • Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
  • Use of Isotretinoin or other systemic retinoids within the past 6 months.
  • Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months.
  • Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges.
  • Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
  • History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
  • Having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study.
  • Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment.
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AboutSkin, Dermatology and Derm Surgery PC

Englewood, Colorado, 80113, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Related Publications (3)

  • Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.

    PMID: 24085055BACKGROUND

  • Weiss ET, Chapas A, Brightman L, Hunzeker C, Hale EK, Karen JK, Bernstein L, Geronemus RG. Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement. Arch Dermatol. 2010 Feb;146(2):133-40. doi: 10.1001/archdermatol.2009.358.

    PMID: 20157023BACKGROUND

  • Alster T. Laser scar revision: comparison study of 585-nm pulsed dye laser with and without intralesional corticosteroids. Dermatol Surg. 2003 Jan;29(1):25-9. doi: 10.1046/j.1524-4725.2003.29024.x.

    PMID: 12534508BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shlomit Mann, MSc

    Syneron Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

February 1, 2013

Primary Completion

February 1, 2016

Study Completion

September 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

US(2)