N/A
N=100
Comparison of Lasers in the Treatment of Scars
Scar
Bottom Line
View on ClinicalTrials.gov: NCT02988622 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Scar Pain — 1.265; 1.181; 1.048; 1.084 units on a scale — p=0.0492
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fraxel Laser (Device); CO2 Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marta Hemmingson-Van Beek
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scar Pain |
1.265; 1.181; 1.048; 1.084 | 0.0492 sig |
| PRIMARY Scar Itching |
1.386; 1.337; 1.084; 1.277 | 0.0817 |
| PRIMARY Scar Color |
5.622; 5.518; 4.108; 4.313 | 0.0686 |
| PRIMARY Scar Stiffness |
4.361; 4.518; 3.313; 3.386 | 0.6278 |
| PRIMARY Scar Thickness |
5.325; 5.145; 3.373; 3.530 | 0.0848 |
| PRIMARY Scar Irregularity |
6.602; 6.500; 3.3964; 4.084 | 0.3418 |
| PRIMARY Overall Opinion |
6.695; 6.654; 4.024; 4.207 | 0.1752 |
| PRIMARY Patient Satisfaction |
0; 0; 2; 3; 10; 9 | — |
| PRIMARY Observer Total Score |
-0.3238; 0.0586 | 0.0281 sig |
Summary
The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to as Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional laser (referred to as CO2 Laser in this application) to determine if one is superior to the other in improving the appearance of scars over a series of three treatments. In addition, the investigators hope to identify a more cost-effective method to improve the appearance of scars caused by surgery or trauma.
Eligibility Criteria
Inclusion Criteria
- Age 18 or older.
- Fitzpatrick skin type I-IV.
- Scars secondary to surgery or trauma.
- Scar length minimum 4 cm in length.
Exclusion Criteria
- Scars less than 6 weeks old.
- History of keloid scarring.
- Use of isotretinoin currently or within 3 months of enrollment
- Use of photosensitive medication currently or within 3 months of enrollment.
- Pregnancy -
Data sourced from ClinicalTrials.gov (NCT02988622). 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.