Scars
Conditions
Brief summary
Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery.
Detailed description
Prospective, Randomized, Split lesion treatment with 4 study Arms: 1) treatment with pulsed dye laser (PDL) only, 2) treatment with CO2 laser only, 3) PDL and CO2 laser combined treatment, and 4) split scar combined lasers with an additional single CO2 laser treatment immediately post-surgery vs. no treatment.
Interventions
Scar minimization with Pulsed dye laser treatment on suture removal day
DEVICECO2 laser treatment
Scar minimization with CO2 laser treatment on suture removal day
DEVICECombined PDL and CO2 laser treatment
Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day
DEVICESplit PDL and CO2 Laser treatment
Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day
Sponsors
Syneron Medical
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Comprehension of, and willingness to sign, the Informed Consent Form. * Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm. * Be a healthy male or female of at least 18 years old. * Fitzpatrick skin type I-V. * Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions. * Non pregnant and/or breast feeding, if applicable. * Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months. * Agree to follow and undergo all study-related procedures. * Use of daily use of sunblock SPF 30 or higher for duration of the study.
Exclusion criteria
1. Pregnant and/or breastfeeding. 2. Fitzpatrick skin type VI. 3. Prior treatment for the surgical scar to be treated in this study. 4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen. 5. Use of Isotretinoin or other systemic retinoids within the past 6 months. 6. Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months. 7. Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges. 8. Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions. 9. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. 10. Having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study. 11. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study. 12. Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment. 13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline | Baseline, 3 months after final treatment | Blinded review of 7-point Global Evaluation Response (GER) scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline | Baseline, 3 months after final treatment | Investigator review of VSS - The VSS assesses four variables: vascularity, pigmentation, pliability, and height of the scar, to provide an overall score from 0 (normal) to 13 (severe). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of adverse events | Baseline and up to 3 months after treatment | Number and severity of adverse events |
Countries
United States
Outcome results
None listed