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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT01789346
First received: February 7, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Cutera Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789346

Locations
United States, District of Columbia
Washington Institute of Dermatologic Laser Surgery
Washington, District of Columbia, United States, 20005
Sponsors and Collaborators
Cutera Inc.
  More Information

No publications provided

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT01789346     History of Changes
Other Study ID Numbers: C-12-EV3
Study First Received: February 7, 2013
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cutera Inc.:
Scar
Scars
Surgical Scar
Surgical Scars
Cicatrix
Hypertrophic Cicatrix
Keloid
Hypertrophic Scar
Surgical Incision
Scarring
Abdominoplasty
Tummy Tuck
Augmentation Mammoplasty
Breast Augmentation
Thyroidectomy

Additional relevant MeSH terms:
Hypertrophy
Keloid
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014