Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

NCT ID: NCT01826942

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-03-31

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.

Conditions

Scar Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thin skin

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

Group Type: EXPERIMENTAL

Lumenis UltraPulse single fractional CO2 laser treatment thin skin

Intervention Type: DEVICE

Thick skin

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Interventions

Lumenis UltraPulse single fractional CO2 laser treatment thin skin

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ronald L. Moy, M.D.

Beverly Hills, California, United States

Countries

United States

Other Identifiers

LUM-ABU-UP-13-01

Identifier Type: -

Identifier Source: org_study_id