Cicatrix, Cicatrix, Hypertrophic, Keloid, Scar, Surgical Scar
Conditions
Keywords
Scar, Scars, Surgical Scar, Surgical Scars, Cicatrix, Hypertrophic Cicatrix, Keloid, Hypertrophic Scar, Surgical Incision, Scarring, Abdominoplasty, Tummy Tuck, Augmentation Mammoplasty, Breast Augmentation, Thyroidectomy
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.
Interventions
Sponsors
Cutera Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects treated with Cutera ExcelV 532nm KTP laser or Cynosure Cynergy 595nm pulsed-dye laser | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Subjects | — |
|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 11.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 10 / 19 | 8 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
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
Time frame: 12-weeks post-final laser treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 532nm KTP Laser | Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms. | 2.0 score on a scale |
| 595nm PDL | Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms. | 1.5 score on a scale |