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

Primary Purpose

Scar, Surgical Scar, Cicatrix

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
532nm KTP
595nm PDL
Sponsored by
Cutera Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring Scar, Scars, Surgical Scar, Surgical Scars, Cicatrix, Hypertrophic Cicatrix, Keloid, Hypertrophic Scar, Surgical Incision, Scarring, Abdominoplasty, Tummy Tuck, Augmentation Mammoplasty, Breast Augmentation, Thyroidectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington Institute of Dermatologic Laser Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

532nm KTP

595nm PDL

Arm Description

Cutera ExcelV 532nm potassium titanyl phosphate (KTP) laser

Cynosure Cynergy 595nm pulsed-dye (PDL) laser

Outcomes

Primary Outcome Measures

Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.
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

Secondary Outcome Measures

Full Information

First Posted
February 7, 2013
Last Updated
January 26, 2023
Sponsor
Cutera Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01789346
Brief Title
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
Official Title
Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 26, 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutera Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Surgical Scar, Cicatrix, Cicatrix, Hypertrophic, Keloid
Keywords
Scar, Scars, Surgical Scar, Surgical Scars, Cicatrix, Hypertrophic Cicatrix, Keloid, Hypertrophic Scar, Surgical Incision, Scarring, Abdominoplasty, Tummy Tuck, Augmentation Mammoplasty, Breast Augmentation, Thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
532nm KTP
Arm Type
Other
Arm Description
Cutera ExcelV 532nm potassium titanyl phosphate (KTP) laser
Arm Title
595nm PDL
Arm Type
Active Comparator
Arm Description
Cynosure Cynergy 595nm pulsed-dye (PDL) laser
Intervention Type
Device
Intervention Name(s)
532nm KTP
Other Intervention Name(s)
ExcelV laser, Cutera ExcelV, Excel V
Intervention Description
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
Intervention Type
Device
Intervention Name(s)
595nm PDL
Other Intervention Name(s)
Cynosure Cynergy, Cynergy laser
Intervention Description
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
Primary Outcome Measure Information:
Title
Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.
Description
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
Time Frame
12-weeks post-final laser treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Alster, MD
Organizational Affiliation
Washington Institute of Dermatologic Laser Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Tanzi, MD
Organizational Affiliation
Washington Institute of Dermatologic Laser Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Institute of Dermatologic Laser Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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