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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. Identifier: NCT01789346
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
Cutera Inc.

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.

Condition or disease Intervention/treatment Phase
Scar Surgical Scar Cicatrix Cicatrix, Hypertrophic Keloid Device: 532nm potassium titanyl phosphate (KTP) laser Device: 595nm pulsed-dye laser (PDL) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2013
Actual Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium Scars

Arm Intervention/treatment
532nm KTP laser
Cutera ExcelV 532nm KTP laser
Device: 532nm potassium titanyl phosphate (KTP) laser
Other Names:
  • ExcelV laser
  • Cutera ExcelV
  • Excel V

Active Comparator: 595nm PDL
Cynosure Cynergy 595nm pulsed-dye laser
Device: 595nm pulsed-dye laser (PDL)
Other Names:
  • Cynosure Cynergy
  • Cynergy laser

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01789346

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United States, District of Columbia
Washington Institute of Dermatologic Laser Surgery
Washington, District of Columbia, United States, 20005
Sponsors and Collaborators
Cutera Inc.
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Responsible Party: Cutera Inc. Identifier: NCT01789346    
Other Study ID Numbers: C-12-EV3
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by Cutera Inc.:
Surgical Scar
Surgical Scars
Hypertrophic Cicatrix
Hypertrophic Scar
Surgical Incision
Tummy Tuck
Augmentation Mammoplasty
Breast Augmentation
Additional relevant MeSH terms:
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Cicatrix, Hypertrophic
Pathologic Processes
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases