Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

This study has been terminated.
(Cooperation stooped with PI)
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.
ClinicalTrials.gov Identifier:
NCT01826942
First received: April 4, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Scar Prevention
Device: Lumenis UltraPulse single fractional CO2 laser treatment thin skin
Device: Single fractional CO2 treatment at surgical area closure procedure on thick skin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

Resource links provided by NLM:


Further study details as provided by Lumenis Ltd.:

Primary Outcome Measures:
  • Scar appearance by blinded evaluation of photographs of the three month follow-up visit [ Time Frame: three month follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thin skin
Single fractional CO2 treatment at surgical area closure procedure on thin skin
Device: Lumenis UltraPulse single fractional CO2 laser treatment thin skin
Experimental: Thick skin
Single fractional CO2 treatment at surgical area closure procedure on thick skin
Device: Single fractional CO2 treatment at surgical area closure procedure on thick skin

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826942

Locations
United States, California
Ronald L. Moy, M.D.
Beverly Hills, California, United States, 90210
Sponsors and Collaborators
Lumenis Ltd.
  More Information

No publications provided

Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT01826942     History of Changes
Other Study ID Numbers: LUM-ABU-UP-13-01
Study First Received: April 4, 2013
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lumenis Ltd.:
Scar prevention
CO2 fractional laser

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014