- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01858038
Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital - Wellman Center for Photomedicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who are healthy with ages between 18 and 50 years.
- Subjects who have had their most recent abdominal procedure at least 2 years prior to enrollment in study.
- Subjects with surgical scars with a length greater than 10 cm or 4 inches.
- Subjects whose scars are either hypertrophic or atrophic but enlarged.
- Subjects who are willing to participate in the study.
- Subjects who are willing to receive laser treatment.
- Subjects who are willing to receive skin biopsies.
- Subjects who agree and sign an informed consent relating to study procedures.
- Subjects who are willing to follow the treatment schedule and post-treatment care requirements.
- 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.
- Subjects who are willing to avoid topical or systemic scar treatment, including topical over-the-counter (OTC) corticosteroids, during the study period.
Exclusion Criteria:
- Subjects with underlying skin or other medical conditions that could have an adverse effect on wound healing.
- Subjects with evidence of infection on area to be treated or elsewhere on body.
- Subjects with presence of suntan in the area to be treated.
- Subjects who have had topical/Injected corticosteroids within 1 month of entering the study.
- Subjects with known anticoagulation or thromboembolic condition.
- Subjects who are immunosuppressed.
- Subjects who are unable to comply with treatment, home care, or follow-up visits.
- Subjects who are pregnant or breast-feeding.
- Subjects with known autoimmune disease.
- Subjects who are enrolled in any other clinical trial using systemic medication; or any other treatment that might interfere with this study.
Subjects with known diabetes mellitus
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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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
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mRNA (messenger ribonucleic acid) expression
Time Frame: at 8 weeks
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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. |
at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Efficacy
Time Frame: 8 weeks and 10 weeks
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Vancouver Scar Scale (VSS) and Matching Assessment Using Photographs and Scars (MAPS) for scars
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8 weeks and 10 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing Subject Side-effects and Satisfaction
Time Frame: 8 weeks and 10 weeks
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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.
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8 weeks and 10 weeks
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-P-002618
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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