Hypertrophic ScarsNCT01858038
Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis
A study testing Fraxel Repair - Fractional Laser treatment in people with Hypertrophic Scars, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- Fraxel Repair - Fractional Laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - Wellman Center for Photomedicine
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Hypertrophic Scars
- Being tested
- Fraxel Repair - Fractional Laser treatment
- Keywords
- Scar
- Medical subject headings
- Cicatrix, Hypertrophic, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraxel Repair - Fractional Laser treatmentDevice
Also called Fraxel Repair, Solta Medical, Hayward, CA
An FDA-approved Fractional 10,600 nm laser source will be used for laser exposures performed 2 months prior to biopsies of treated sites
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Fraxel Repair - Fractional Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 8 weeks
Secondary outcomes (1)
Evaluation of Efficacy
Vancouver Scar Scale (VSS) and Matching Assessment Using Photographs and Scars (MAPS) for scars
Measured: 8 weeks and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionDec 2014
Why it stopped: Not enough subjects interested in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- R.Rox Anderson, MD, Principal investigator, Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical SchoolFernanda H Sakamoto, MD, PhD, Study director, Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858038
- Sponsor's protocol ID
- 2010-P-002618
- Status last verified
- Sep 2019
- First submitted
- 16 May 2013
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis
- ClinicalTrials.gov ID
- NCT01858038
- Acronym / sponsor ID
- 2010-P-002618
- Conditions
- Hypertrophic Scars
- Keywords
- Scar
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough subjects interested in this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Fraxel Repair - Fractional Laser treatmentIntervention: An FDA-approved Fractional 10,600 nm laser source will be used for laser exposures performed 2 months prior to biopsies of treated sites |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fraxel Repair - Fractional Laser treatmentAlso: Fraxel Repair, Solta Medical, Hayward, CAAn FDA-approved Fractional 10,600 nm laser source will be used for laser exposures performed 2 months prior to biopsies of treated sites | Device | Intervention Fractional Laser treatment |
Primary outcome
mRNA (messenger ribonucleic acid) expression
Time frame: at 8 weeks
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.
1 secondary outcome
Evaluation of Efficacy
Time frame: 8 weeks and 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R.Rox Anderson, MD principal investigator
Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical School
Fernanda H Sakamoto, MD, PhD study director
Massachusetts General Hospital - Wellman Center for Photomedicine - Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraxel Repair - Fractional Laser treatment in people with Hypertrophic Scars, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA (messenger ribonucleic acid) expression (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.