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Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

Primary Purpose

Scar Prevention

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lumenis UltraPulse single fractional CO2 laser treatment thin skin

Single fractional CO2 treatment at surgical area closure procedure on thick skin

About this trial

This is an interventional treatment trial for Scar Prevention focused on measuring Scar prevention, CO2 fractional laser

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or Females
At least 18 and no more than 65 years old
The surgical area closure in these subjects should be at least 4cm
Type of surgery scheduled:

Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure)

Willing to comply with study dosing and complete the entire course of the study

Exclusion Criteria:

Active bacterial, fungal, or viral infection in the treatment area
Active cold sores, or herpes in the treatment area
Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes.
History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis)
Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics)
History or presenting with a keloid scar
Any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes.
Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator
Female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding
Small surgical closure (<4cm)

Sites / Locations

Ronald L. Moy, M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Thin skin

Thick skin

Arm Description

Single fractional CO2 treatment at surgical area closure procedure on thin skin

Single fractional CO2 treatment at surgical area closure procedure on thick skin

Outcomes

Primary Outcome Measures

Scar appearance by blinded evaluation of photographs of the three month follow-up visit

Secondary Outcome Measures

Full Information

NCT ID

NCT01826942

First Posted

April 4, 2013

Last Updated

March 25, 2014

Sponsor

Lumenis Be Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01826942

Brief Title

Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

Official Title

Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Why Stopped

Cooperation stooped with PI

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lumenis Be Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. The investigators will also evaluate the effect of shallow fractional laser treatment versus deep parameters settings. If effective treatments could be performed at time of surgery, this would result in both time and cost saving to the patient and to the healthcare system and will improve patient's self-image post surgeries.

6. Conditions and Keywords

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

Scar Prevention

Keywords

Scar prevention, CO2 fractional laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thin skin

Arm Type

Experimental

Arm Description

Single fractional CO2 treatment at surgical area closure procedure on thin skin

Arm Title

Thick skin

Arm Type

Experimental

Arm Description

Single fractional CO2 treatment at surgical area closure procedure on thick skin

Intervention Type

Device

Intervention Name(s)

Lumenis UltraPulse single fractional CO2 laser treatment thin skin

Intervention Type

Device

Intervention Name(s)

Single fractional CO2 treatment at surgical area closure procedure on thick skin

Primary Outcome Measure Information:

Title

Scar appearance by blinded evaluation of photographs of the three month follow-up visit

Time Frame

three month follow-up

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: Male or Females At least 18 and no more than 65 years old The surgical area closure in these subjects should be at least 4cm Type of surgery scheduled: Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure) Willing to comply with study dosing and complete the entire course of the study Exclusion Criteria: Active bacterial, fungal, or viral infection in the treatment area Active cold sores, or herpes in the treatment area Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes. History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis) Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics) History or presenting with a keloid scar Any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes. Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator Female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding Small surgical closure (<4cm)

Facility Information:

Facility Name

Ronald L. Moy, M.D.

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

12. IPD Sharing Statement

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Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

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