Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/2/2016 |
| Start Date: | May 2013 |
| End Date: | December 2014 |
| Contact: | Fernanda H Sakamoto, MD, PhD |
| Email: | fsakamoto@partners.org |
| Phone: | 617-7245329 |
This project aims to understand the molecular biology underlying the improvement of surgical
scars treated by ablative fractional photothermolysis (FP). Previous human studies at MGH
have shown that FP significantly improves the appearance and functionality of surgical and
burn scars. At the Wellman Center, we have conducted a randomized, controlled study on
linear surgical scars demonstrating the efficacy of FP to decrease the volume of
hypertrophic scars, and to improve the appearance and texture of scars. However, the
underlying mechanism of this therapeutic effect is unknown. It is clear that FP induces
wound healing and remodeling of the normal skin surrounding microthermal zones (MTZs).
Furthermore, other researchers have employed animal models using transgenic zebrafish and
the mouse eye, and found that laser treatments induce changes in gene expression in specific
cells. We propose to determine whether the effect of FP on scar improvement occurs via
changes in patterns of local gene expression within the skin, specifically dermal
fibroblasts. By characterizing these changes, we may be able to identify molecular
mechanisms that both explain and contribute to the beneficial effects of FP in the surgical
and traumatic scar. The molecular insights into the therapeutic effects of fractional laser
photothermolysis may provide a basis for future therapeutic strategies to improve scar
remodeling.
scars treated by ablative fractional photothermolysis (FP). Previous human studies at MGH
have shown that FP significantly improves the appearance and functionality of surgical and
burn scars. At the Wellman Center, we have conducted a randomized, controlled study on
linear surgical scars demonstrating the efficacy of FP to decrease the volume of
hypertrophic scars, and to improve the appearance and texture of scars. However, the
underlying mechanism of this therapeutic effect is unknown. It is clear that FP induces
wound healing and remodeling of the normal skin surrounding microthermal zones (MTZs).
Furthermore, other researchers have employed animal models using transgenic zebrafish and
the mouse eye, and found that laser treatments induce changes in gene expression in specific
cells. We propose to determine whether the effect of FP on scar improvement occurs via
changes in patterns of local gene expression within the skin, specifically dermal
fibroblasts. By characterizing these changes, we may be able to identify molecular
mechanisms that both explain and contribute to the beneficial effects of FP in the surgical
and traumatic scar. The molecular insights into the therapeutic effects of fractional laser
photothermolysis may provide a basis for future therapeutic strategies to improve scar
remodeling.
A prospective, open-label study in 10 healthy adults, ages 18-50, with abdominal scars will
be pursued at the Clinical Research Unit at Wellman Center for Photomedicine (MGH). A
side-by-side comparison of untreated vs. one topical treatment of ablative fractional
photothermolysis in qualifying subjects will be made. Ten subjects will receive treatment on
randomly-assigned portions of their scars, in addition to non-treated control sites. The
primary measures of efficacy are (a) blinded evaluation of scar improvement from standard
digital photographs taken before and after the treatments, (b) changes in scar volume
(measured by 3D Image system) and/or scar width, and (c) a quantitative characterization of
gene expression measured by mRNA expression levels from treated and untreated scars and
control sites. The primary measures of side effects are inflammatory and pigmentary outcomes
assessed by blind evaluation of digital photographs taken before and after the treatments.
Another study endpoint includes histopathological examination and comparison of treated and
untreated scars.
An FDA-approved 10600 nm Fractional laser source will be used for laser exposures performed
2 months prior to 2 skin biopsies (each 24 mm x 4 mm) of treated and untreated scar sites. A
control site, with no treatment will also be left for clinical, histological and molecular
examination.
be pursued at the Clinical Research Unit at Wellman Center for Photomedicine (MGH). A
side-by-side comparison of untreated vs. one topical treatment of ablative fractional
photothermolysis in qualifying subjects will be made. Ten subjects will receive treatment on
randomly-assigned portions of their scars, in addition to non-treated control sites. The
primary measures of efficacy are (a) blinded evaluation of scar improvement from standard
digital photographs taken before and after the treatments, (b) changes in scar volume
(measured by 3D Image system) and/or scar width, and (c) a quantitative characterization of
gene expression measured by mRNA expression levels from treated and untreated scars and
control sites. The primary measures of side effects are inflammatory and pigmentary outcomes
assessed by blind evaluation of digital photographs taken before and after the treatments.
Another study endpoint includes histopathological examination and comparison of treated and
untreated scars.
An FDA-approved 10600 nm Fractional laser source will be used for laser exposures performed
2 months prior to 2 skin biopsies (each 24 mm x 4 mm) of treated and untreated scar sites. A
control site, with no treatment will also be left for clinical, histological and molecular
examination.
Inclusion Criteria:
1. Subjects who are healthy with ages between 18 and 50 years.
2. Subjects who have had their most recent abdominal procedure at least 2 years prior to
enrollment in study.
3. Subjects with surgical scars with a length greater than 10 cm or 4 inches.
4. Subjects whose scars are either hypertrophic or atrophic but enlarged.
5. Subjects who are willing to participate in the study.
6. Subjects who are willing to receive laser treatment.
7. Subjects who are willing to receive skin biopsies.
8. Subjects who agree and sign an informed consent relating to study procedures.
9. Subjects who are willing to follow the treatment schedule and post-treatment care
requirements.
10. Subjects who had not received any topical treatment for scars in the past month,
including corticosteroid injections, topical fluorinated corticosteroids or any other
laser treatment.
11. Subjects who are willing to avoid topical or systemic scar treatment, including
topical over-the-counter (OTC) corticosteroids, during the study period.
Exclusion Criteria:
1. Subjects with underlying skin or other medical conditions that could have an adverse
effect on wound healing.
2. Subjects with evidence of infection on area to be treated or elsewhere on body.
3. Subjects with presence of suntan in the area to be treated.
4. Subjects who have had topical/Injected corticosteroids within 1 month of entering the
study.
5. Subjects with known anticoagulation or thromboembolic condition.
6. Subjects who are immunosuppressed.
7. Subjects who are unable to comply with treatment, home care, or follow-up visits.
8. Subjects who are pregnant or breast-feeding.
9. Subjects with known autoimmune disease.
10. Subjects who are enrolled in any other clinical trial using systemic medication; or
any other treatment that might interfere with this study.
11. Subjects with known diabetes mellitus
We found this trial at
1
site
Click here to add this to my saved trials
