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Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

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ClinicalTrials.gov Identifier: NCT01826942
Recruitment Status : Terminated (Cooperation stooped with PI)
First Posted : April 9, 2013
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.

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.

Condition or disease Intervention/treatment
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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scar Prevention Using Fractional Carbon Dioxide Laser Treatment
Study Start Date : January 2013
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Scar appearance by blinded evaluation of photographs of the three month follow-up visit [ Time Frame: three month follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826942


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

Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT01826942     History of Changes
Other Study ID Numbers: LUM-ABU-UP-13-01
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

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