Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis

This study is currently recruiting participants.
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Richard Rox Anderson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01858038
First received: May 16, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hypertrophic Scars
Device: Fraxel Repair - Fractional Laser treatment
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 10
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858038

Contacts
Contact: Fernanda H Sakamoto, MD, PhD 617-7245329 fsakamoto@partners.org
Contact: Kimberli Bell 617-7244937 kbell2@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital - Wellman Center for Photomedicine Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kimberli Bell    617-724-4937    kbell2@partners.org   
Contact: Fernanda H Sakamoto, MD, PhD, MD, PhD       fsakamoto@partners.org   
Principal Investigator: R. Rox Anderson, MD         
Sub-Investigator: Fernanda H Sakamoto, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
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
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Rox Anderson, MD, MD, Director of the Wellman Center for Photomedicine, Professor in Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01858038     History of Changes
Other Study ID Numbers: 2010-P-002618
Study First Received: May 16, 2013
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Scar

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014