Comparison of Lasers in the Treatment of Scars
| Status: | Completed |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 10/20/2018 |
| Start Date: | January 2016 |
| End Date: | January 15, 2018 |
1550-nm Non Ablative Laser (Fraxel) Versus Ablative 10,600-nm Carbon Dioxide (CO2) Fractional Laser in the Treatment of Surgical and Traumatic Scars: A Comparison Study on Efficacy, Treatment Regimen, and Cost.
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.
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.
This study will be accomplished through a controlled split-scar study design whereby half of
the scar will be treated with the Fraxel Laser and the other half of the scar will be treated
with the CO2 Laser. This study is a blinded, prospective comparative, split-scar study
whereby 100 participants will be recruited, enrolled and followed for a period of 9 months.
The study population will include male and female participants, age 18 and over with scars
secondary to surgery or trauma on any part of the body. The study will recruit participants
with light colored skin, Fitzpatrick Type I-IV, because colored skin has a significantly
higher risk of keloid scarring. The scar must measure a minimum of 4 cm in length to
accommodate for the split-scar treatment. The participants will undergo laser treatments on
Visit 1, Visit 2 and Visit 3 and each visit will be 4 weeks apart. The participants will
return for evaluation and follow-up 3 months and 6 months following the last laser treatment.
At each visit, photographs will be taken using identical camera settings, lighting and
participant positioning. Evaluation of the scars will be completed by the participants and by
blinded dermatology physicians. Participants will use a complete visual analogue scale at
each visit, the Patient and Observer Scar Assessment Scale (POSAS) and a satisfaction score.
the scar will be treated with the Fraxel Laser and the other half of the scar will be treated
with the CO2 Laser. This study is a blinded, prospective comparative, split-scar study
whereby 100 participants will be recruited, enrolled and followed for a period of 9 months.
The study population will include male and female participants, age 18 and over with scars
secondary to surgery or trauma on any part of the body. The study will recruit participants
with light colored skin, Fitzpatrick Type I-IV, because colored skin has a significantly
higher risk of keloid scarring. The scar must measure a minimum of 4 cm in length to
accommodate for the split-scar treatment. The participants will undergo laser treatments on
Visit 1, Visit 2 and Visit 3 and each visit will be 4 weeks apart. The participants will
return for evaluation and follow-up 3 months and 6 months following the last laser treatment.
At each visit, photographs will be taken using identical camera settings, lighting and
participant positioning. Evaluation of the scars will be completed by the participants and by
blinded dermatology physicians. Participants will use a complete visual analogue scale at
each visit, the Patient and Observer Scar Assessment Scale (POSAS) and a satisfaction score.
Inclusion Criteria:
1. Age 18 or older.
2. Fitzpatrick skin type I-IV.
3. Scars secondary to surgery or trauma.
4. Scar length minimum 4 cm in length.
Exclusion Criteria:
1. Scars less than 6 weeks old.
2. History of keloid scarring.
3. Use of isotretinoin currently or within 3 months of enrollment
4. Use of photosensitive medication currently or within 3 months of enrollment.
5. Pregnancy -
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