Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

Scar Prevention Clinical Trial

Official title:

Scar Prevention Using Fractional Carbon Dioxide Laser Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01826942
• Other study ID #: LUM-ABU-UP-13-01
• Status: Terminated
• Phase: N/A
• First received: April 4, 2013
• Last updated: March 25, 2014
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scar Prevention

Intervention

Device:
• Lumenis UltraPulse single fractional CO2 laser treatment thin skin

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

Locations

Country	Name	City	State
United States	Ronald L. Moy, M.D.	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar appearance by blinded evaluation of photographs of the three month follow-up visit		three month follow-up	Yes