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Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01789346
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Tracking Information
First Submitted Date  ICMJE February 7, 2013
First Posted Date  ICMJE February 12, 2013
Last Update Posted Date July 29, 2014
Study Start Date  ICMJE February 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
Comparison of percentage improvement in surgical scar between treatment (532nm KTP laser) and active control (595nm PDL) treatment arms. [ Time Frame: 12-weeks post-final laser treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Scar
  • Surgical Scar
  • Cicatrix
  • Cicatrix, Hypertrophic
  • Keloid
Intervention  ICMJE
  • Device: 532nm potassium titanyl phosphate (KTP) laser
    Other Names:
    • ExcelV laser
    • Cutera ExcelV
    • Excel V
  • Device: 595nm pulsed-dye laser (PDL)
    Other Names:
    • Cynosure Cynergy
    • Cynergy laser
Study Arms  ICMJE
  • 532nm KTP laser
    Cutera ExcelV 532nm KTP laser
    Intervention: Device: 532nm potassium titanyl phosphate (KTP) laser
  • Active Comparator: 595nm PDL
    Cynosure Cynergy 595nm pulsed-dye laser
    Intervention: Device: 595nm pulsed-dye laser (PDL)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fitzpatrick Skin Type I - IV
  • Has postoperative linear scar(s) which is one to twelve months post-surgery.
  • Having one scar that measures a minimum of 5 cm in length or two scars (bilateral) each measure a minimum of 2 cm in length.
  • Be in good health.
  • Must agree not to undergo any other procedure for the treatment of scar during the study.
  • Willing to refrain from excess sun exposure and willing to wear sunscreen on the treated scar during the study (including the follow-up period).
  • Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria:

  • Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
  • Having received any prior treatment for the target surgical scar.
  • Pregnant and/or breastfeeding.
  • Significant concurrent illness, malignant tumors in the target area, acute or chronic skin infection/inflammation, currently using immunosuppressive medications or currently undergoing systemic chemotherapy.
  • Current use of any medication known to increase sensitivity to light or taking prescription anticoagulation medication.
  • History of abnormal or delayed wound healing, keloid formation or pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  • History of malignant skin disease, immune deficiency disorders, seizure disorders due to light, or diseases stimulated by heat, unless prophylactic measures taken prior to treatment.
  • Systemic use of isotretinoin within 6 months or corticosteroids within 12 months of study participation.
  • Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  • Current smoker or history of smoking within 12 months of study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01789346
Other Study ID Numbers  ICMJE C-12-EV3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cutera Inc.
Study Sponsor  ICMJE Cutera Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cutera Inc.
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP