Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis
Device: Fraxel Repair - Fractional Laser treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis|
- mRNA (messenger ribonucleic acid) expression [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
Gene array analysis will be performed with the Affymetrix Expression ConsoleTM software, which contains commonly used probe set summarization algorithms, including the MAS5 Statistical algorithm, Probe Logarithmic Intensity Error Estimation (PLIER), and the Robust Multichip Analysis (RMA).
Additional statistical analysis will be performed using the SPSS statistical package (version 16.0, SPSS Inc., Chicago, IL). All two-tailed values of P < 0.05 will be considered statistically significant.
- Evaluation of Efficacy [ Time Frame: 8 weeks and 10 weeks ] [ Designated as safety issue: No ]Vancouver Scar Scale (VSS) and Matching Assessment Using Photographs and Scars (MAPS) for scars
- Assessing Subject Side-effects and Satisfaction [ Time Frame: 8 weeks and 10 weeks ] [ Designated as safety issue: Yes ]In this survey, subjects are given a list of the treatment side effects before treatment (Visit 1, 2) and are asked to rate each question on a scale of 1 to 5. After treatment, they are given this specific survey (but specific to the treatment site) at each subsequent visit as a repeated measure of side effects. Because subjects will be blinded to the treatment assignment (though sites may become obvious), they will be asked the question based on the treatment site name. Treatment site assignments will be kept with study investigators.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control
The scar will be randomized and demarcated as the following: (1) treatment site and (2) control site (no treatment, no intervention) The treatment condition assigned for each site will be kept the same for all following treatment sessions
Experimental: Intervention Fractional Laser treatment
Intervention: An FDA-approved Fractional 10,600 nm laser source will be used for laser exposures performed 2 months prior to biopsies of treated sites
Device: Fraxel Repair - Fractional Laser treatment
An FDA-approved Fractional 10,600 nm laser source will be used for laser exposures performed 2 months prior to biopsies of treated sites
Other Name: Fraxel Repair, Solta Medical, Hayward, CA
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858038
|Contact: Fernanda H Sakamoto, MD, PhDemail@example.com|
|Contact: Kimberli Bellfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital - Wellman Center for Photomedicine||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Kimberli Bell 617-724-4937 email@example.com|
|Contact: Fernanda H Sakamoto, MD, PhD, MD, PhD firstname.lastname@example.org|
|Principal Investigator: R. Rox Anderson, MD|
|Sub-Investigator: Fernanda H Sakamoto, MD, PhD|
|Principal Investigator:||R.Rox Anderson, MD||Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical School|
|Study Director:||Fernanda H Sakamoto, MD, PhD||Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical School|