PDL and Fractional Photothermolysis for Postsurgical Scars
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/28/2018 |
| Start Date: | March 1, 2017 |
| End Date: | December 2018 |
The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars
This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser)
and fractional photothermolysis in the cosmetic improvement of post surgical scars.All
subjects will be offered at the time of the dermatologic procedure, an option to treat the
post surgical scars with early combined PDL and fractional photothermolysis.
Part A is a non-randomized study design and subjects will have the choice of whether or not
they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs.
control design.
The experimental group will have a total of 6 visits: 1 standard of care suture removal
visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1
standard of care suture removal visit and 2 follow up visits.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion
criteria will be considered for enrollment.
This study is a pilot study designed to determine feasibility of this procedure.
and fractional photothermolysis in the cosmetic improvement of post surgical scars.All
subjects will be offered at the time of the dermatologic procedure, an option to treat the
post surgical scars with early combined PDL and fractional photothermolysis.
Part A is a non-randomized study design and subjects will have the choice of whether or not
they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs.
control design.
The experimental group will have a total of 6 visits: 1 standard of care suture removal
visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1
standard of care suture removal visit and 2 follow up visits.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion
criteria will be considered for enrollment.
This study is a pilot study designed to determine feasibility of this procedure.
Inclusion Criteria:
1. Males or females ≥ 18 years old
2. Fitzpatrick skin types I-VI
3. Subjects are in good health as judged by the investigator.
4. Subjects who have received dermatologic surgery procedure of the trunk or extremities
closed with complex primary closure with subcuticular running suture removed at 2-3
weeks.
5. Subjects applying topical retinoids, must discontinue one week prior to treatment.
6. Subjects who are willing and have the ability to understand and provide informed
consent for participation in the study and are able to communicate with the
investigator.
Exclusion Criteria:
1. History of recurrent facial or labial herpes simplex infection
2. Subjects applying topical retinoids, must discontinue one week prior to treatment.
3. Subjects with a history of hypertrophic scars or keloids
4. Pregnant or breast feeding
5. Uncooperative patients or patients with neurological disorders who are incapable of
following directions or who are predictably unwilling to return for follow-up
examinations.
6. Subjects who are unable to understand the protocol or give informed consent.
7. Subjects who in the opinion of the investigator are likely to have exaggerated
scarring with laser treatments.
We found this trial at
1
site
Chicago, Illinois 60611
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