Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 7, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
February 21, 2023
CompletedFebruary 21, 2023
January 1, 2023
1.1 years
February 7, 2013
March 12, 2018
January 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12-weeks post-final laser treatment
Study Arms (2)
532nm KTP
OTHERCutera ExcelV 532nm potassium titanyl phosphate (KTP) laser
595nm PDL
ACTIVE COMPARATORCynosure Cynergy 595nm pulsed-dye (PDL) laser
Interventions
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cutera Inc.lead
Study Sites (1)
Washington Institute of Dermatologic Laser Surgery
Washington D.C., District of Columbia, 20005, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Margot Doucette
- Organization
- Cutera
Study Officials
- PRINCIPAL INVESTIGATOR
Tina Alster, MD
Washington Institute of Dermatologic Laser Surgery
- PRINCIPAL INVESTIGATOR
Elizabeth Tanzi, MD
Washington Institute of Dermatologic Laser Surgery
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2013
First Posted
February 12, 2013
Study Start
February 1, 2013
Primary Completion
March 26, 2014
Study Completion
December 1, 2014
Last Updated
February 21, 2023
Results First Posted
February 21, 2023
Record last verified: 2023-01