Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis

NCT01858038 | Withdrawn

• 1 other identifier: 2010-P-002618
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scars

Keywords

Scar

Outcome Measures

Primary Outcomes (1)

• 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.

  at 8 weeks

Secondary Outcomes (1)

• Evaluation of Efficacy

  8 weeks and 10 weeks

Other Outcomes (1)

• Assessing Subject Side-effects and Satisfaction

  8 weeks and 10 weeks

Study Arms (2)

Control

NO INTERVENTION

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 Fractional Laser treatment

EXPERIMENTAL

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

Interventions

Fraxel Repair - Fractional Laser treatment DEVICE

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

Also known as: Fraxel Repair, Solta Medical, Hayward, CA

Intervention Fractional Laser treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital - Wellman Center for Photomedicine

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• R.Rox Anderson, MD

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

  PRINCIPAL INVESTIGATOR

• Fernanda H Sakamoto, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director of the Wellman Center for Photomedicine, Professor in Dermatology

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

US (1)