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Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis

Primary Purpose

Hypertrophic Scars

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fraxel Repair - Fractional Laser treatment

About this trial

This is an interventional basic science trial for Hypertrophic Scars focused on measuring Scar

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

Massachusetts General Hospital - Wellman Center for Photomedicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention Fractional Laser treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

mRNA (messenger ribonucleic acid) expression

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

Vancouver Scar Scale (VSS) and Matching Assessment Using Photographs and Scars (MAPS) for scars

Full Information

NCT ID

NCT01858038

First Posted

May 16, 2013

Last Updated

September 17, 2019

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01858038

Brief Title

Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis

Official Title

Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Not enough subjects interested in this study

Study Start Date

May 2013 (Actual)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophic Scars

Keywords

Scar

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Arm Title

Intervention Fractional Laser treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Fraxel Repair - Fractional Laser treatment

Other Intervention Name(s)

Fraxel Repair, Solta Medical, Hayward, CA

Intervention Description

An FDA-approved Fractional 10,600 nm laser source will be used for laser exposures performed 2 months prior to biopsies of treated sites

Primary Outcome Measure Information:

Title

mRNA (messenger ribonucleic acid) expression

Description

Time Frame

at 8 weeks

Secondary Outcome Measure Information:

Title

Evaluation of Efficacy

Description

Vancouver Scar Scale (VSS) and Matching Assessment Using Photographs and Scars (MAPS) for scars

Time Frame

8 weeks and 10 weeks

Other Pre-specified Outcome Measures:

Title

Assessing Subject Side-effects and Satisfaction

Description

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.

Time Frame

8 weeks and 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R.Rox Anderson, MD

Organizational Affiliation

Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fernanda H Sakamoto, MD, PhD

Organizational Affiliation

Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical School

Official's Role

Study Director

Facility Information:

Facility Name

Massachusetts General Hospital - Wellman Center for Photomedicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis

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