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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Dye Laser treatment | Active Comparator | Pulsed Dye Laser treatment after suture removal (3 sessions) |
|
| CO2 laser treatment | Active Comparator | CO2 laser (3 treatment sessions) after suture removal |
|
| Combined PDL and CO2 Laser treatment | Active Comparator | Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal |
|
| Split PDL and CO2 Laser treatment | Active Comparator | Half of the scar was not treated and served as a control, while the other half was treated with CO2 ablative fractional resurfacing immediately after surgery, in addition to the three combined PDL and CO2 treatment sessions after suture removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed dye laser treatment | Device | Scar minimization with Pulsed dye laser treatment on suture removal day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline | Blinded review of 7-point Global Evaluation Response (GER) scale | Baseline, 3 months after final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline | 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). | Baseline, 3 months after final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events | Number and severity of adverse events | Baseline and up to 3 months after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shlomit Mann, MSc | Syneron Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AboutSkin, Dermatology and Derm Surgery PC | Englewood | Colorado | 80113 | United States | ||
| Laser & Skin Surgery Center of New York |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24085055 | Background | Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3. | |
| 20157023 | Background | Weiss ET, Chapas A, Brightman L, Hunzeker C, Hale EK, Karen JK, Bernstein L, Geronemus RG. Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement. Arch Dermatol. 2010 Feb;146(2):133-40. doi: 10.1001/archdermatol.2009.358. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| CO2 laser treatment | Device | Scar minimization with CO2 laser treatment on suture removal day |
|
|
| Combined PDL and CO2 laser treatment | Device | Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day |
|
|
| Split PDL and CO2 Laser treatment | Device | Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day |
|
| New York |
| New York |
| 10016 |
| United States |
| 12534508 | Background | Alster T. Laser scar revision: comparison study of 585-nm pulsed dye laser with and without intralesional corticosteroids. Dermatol Surg. 2003 Jan;29(1):25-9. doi: 10.1046/j.1524-4725.2003.29024.x. |