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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)

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

Arm Label

Fresh surgical scars

Mature scars

Arm Description

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

NCT ID

NCT01030198

First Posted

December 10, 2009

Last Updated

December 16, 2020

Sponsor

Cynosure, Inc.

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

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

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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