NCT01030198

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

December 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
10 years until next milestone

Results Posted

Study results publicly available

November 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

December 10, 2009

Results QC Date

April 26, 2013

Last Update Submit

December 16, 2020

Conditions

New Surgical ScarsScars

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)

Study Arms (2)

Fresh surgical scars

EXPERIMENTAL

Treatment of scars

Device: RevLite (Laser Treatment)

Mature scars

EXPERIMENTAL

Treatment of scars

Device: RevLite (Laser Treatment)

Interventions

RevLite (Laser Treatment)DEVICE
Fresh surgical scarsMature scars

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanctuary Medical Aesthetic Center

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.Technical problems with measurement leading to unreliable or uninterpretable data.

Results Point of Contact

Title
Jamie Trimper
Organization
Cynosure, Inc.
jamie.trimper@cynosure.com
800-886-2966

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 11, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 17, 2020

Results First Posted

November 17, 2020

Record last verified: 2020-12

Locations

US(1)