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Laser Treatment for Fresh Surgical Scars and Mature Scars

Primary Purpose

New Surgical Scars, Scars

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RevLite (Laser Treatment)
Sponsored by
Cynosure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for New Surgical Scars

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present [or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration
  • Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)

Exclusion Criteria:

  • Pregnant, lactating, or is planning to become pregnant
  • history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
  • any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy
  • coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
  • any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
  • currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
  • unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
  • unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
  • Isotretinoin therapy within 6 months
  • need to be exposed to artificial tanning devices or excessive sunlight during the trial
  • prior treatment with parenteral gold therapy
  • does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study
  • Diabetes Type 1 or 2
  • Lupus, scleroderma or similar immune system disorder
  • underlying silicone or other non-absorbable filler in the area of the scar
  • phenol chemical peel or dermabrasion to the area of the scar within 3 months
  • Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient

Sites / Locations

  • Sanctuary Medical Aesthetic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fresh surgical scars

Mature scars

Arm Description

Treatment of scars

Treatment of scars

Outcomes

Primary Outcome Measures

Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2009
Last Updated
December 16, 2020
Sponsor
Cynosure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01030198
Brief Title
Laser Treatment for Fresh Surgical Scars and Mature Scars
Official Title
Post-Market, Two-Arm, Single Blind, Controlled Study of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminum Garnet (EO QS Nd:YAG) Laser System for the Treatment of Scars
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
New Surgical Scars, Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fresh surgical scars
Arm Type
Experimental
Arm Description
Treatment of scars
Arm Title
Mature scars
Arm Type
Experimental
Arm Description
Treatment of scars
Intervention Type
Device
Intervention Name(s)
RevLite (Laser Treatment)
Primary Outcome Measure Information:
Title
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
Description
The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.
Time Frame
1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present [or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary) Exclusion Criteria: Pregnant, lactating, or is planning to become pregnant history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy) any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits Isotretinoin therapy within 6 months need to be exposed to artificial tanning devices or excessive sunlight during the trial prior treatment with parenteral gold therapy does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study Diabetes Type 1 or 2 Lupus, scleroderma or similar immune system disorder underlying silicone or other non-absorbable filler in the area of the scar phenol chemical peel or dermabrasion to the area of the scar within 3 months Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient
Facility Information:
Facility Name
Sanctuary Medical Aesthetic Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States

12. IPD Sharing Statement

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Laser Treatment for Fresh Surgical Scars and Mature Scars

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