N/A
N=51
Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy
Cicatrix · Carbon Dioxide Laser
Bottom Line
View on ClinicalTrials.gov: NCT02985151 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group — 0.10; 0.03 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Syneron-Candela CO2RE Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Louis University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group |
0.10; 0.03 | — |
| PRIMARY In Person Blinded Observer POSAS Change V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group |
-3.29; -3.30 | — |
| PRIMARY Change in Vectra Measured Width V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group |
0.06; -0.08 | — |
| PRIMARY Change in Vectra Measured Surface Area V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group |
0.01; -0.04 | — |
| PRIMARY Change in Vectra Measured Length V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group |
0.42; -0.23 | — |
| PRIMARY Change in Vectra Measured Width V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group |
0.19; -1.37 | — |
| PRIMARY Change in Vectra Measured Surface Area V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group |
0.08; -0.05 | — |
| PRIMARY In-person Blinded Observer Change POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group |
-4.95; -5.16 | — |
| PRIMARY Change in Blinded Photo Observer Score POSAS V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group |
-2.36; -2.73 | — |
| PRIMARY Change in Blinded Photo Observer Score on POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group |
-4.18; -4.28 | — |
| SECONDARY Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group |
1.91; 1.98; 0.58; 0.70; 0.41; 0.29 | — |
Summary
This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has not had laser therapy may be eligible to participate. The visits occur every three months for up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a lower energy treatment during the study. Subjects and raters will be blinded to which therapy level the patient receives. At each visit, the scars will be photographed and the subject will complete a questionnaire to rate the scar prior to treatment. Three physicians will evaluate the scar at each visit. One rater will evaluate the scars in person during the visit, while the other two raters will evaluate the scars using photographs after each visit. During the first three study visits, subjects will receive their assigned treatment, obtain post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other skin changes after treatment. At the third study visit, subjects will have the option to receive additional treatments or terminate their participation in the study. The fourth visit for those who continue will be a treatment visit for one group and the fifth visit will be for data collection, with no treatment offered.
Eligibility Criteria
Inclusion Criteria
- Surgical scar present in the head or neck region for at least 8 weeks.
- Capable of providing informed consent
- Available for study appointments
- Follows directions of post-treatment instructions
Exclusion Criteria
- Individuals under the age of 18
- Prior laser treatment to the head or neck
- History of keloid formation
- Isotretinoin use in the last 6 months prior to study enrollment
- Allergy to topical lidocaine
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02985151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.