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

January 26, 2023 updated by: Cutera Inc.

Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20005
        • Washington Institute of Dermatologic Laser Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).
  • Able to read, understand and sign the Informed Consent Form.
  • Willing and able to adhere to the treatment and follow-up schedule, and the post-treatment care instructions.
  • Willingness to have digital photographs taken of the treated scar.
  • 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, coagulation 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 532nm KTP
Cutera ExcelV 532nm potassium titanyl phosphate (KTP) laser
Device: 532nm KTP
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
Other Names:
  • Excel V
  • ExcelV laser
  • Cutera ExcelV
Active Comparator: 595nm PDL
Cynosure Cynergy 595nm pulsed-dye (PDL) laser
Device: 595nm PDL
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
Other Names:
  • Cynosure Cynergy
  • Cynergy laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.
Time Frame: 12-weeks post-final laser treatment
Improvement in surgical scar of 532 nm KTP and 595 nm PDL treatment arms at 12 weeks post-final treatment (compared to baseline) as assessed by blinded independent reviewers Physician's Global Assessment (min=0; max=3) Higher scores mean better outcome
12-weeks post-final laser treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cutera Inc.

Investigators

  • Principal Investigator: Tina Alster, MD, Washington Institute of Dermatologic Laser Surgery
  • Principal Investigator: Elizabeth Tanzi, MD, Washington Institute of Dermatologic Laser Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

March 26, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 12, 2013

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-12-EV03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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