Skin ScarringNCT03306628
Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
A study testing CO2 Laser Administration in people with Skin Scarring, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Skin Scarring
- What is being tested?
- CO2 Laser Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 26 Aug 2019
- 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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of all ethnic origins will be considered, although certain ethnic groups will be preferentially excluded more than others such as black and South Asian patients due to our exclusion criteria related to darker skin individuals (see below).
- Patients undergoing bilateral breast reduction surgery
Who cannot join
- Males will be excluded from this study as male patients rarely undergo breast reduction surgery. When males do undergo breast reduction surgery for gynecomastia, it is often unilateral, and is performed with several techniques and incision types that are not typical employed during female breast reduction. Thus, for this study, only female patients will be considered (see below).
- Any patient enrolled in this study who shows evidence of delayed wound healing, dehiscence, or post operative infection at the first post operative visit will be excluded
- Patients with darker skin (Fitzpatrick IV and above), which is a well-known contraindication to laser therapy
- Pregnant patients
- Patients who have had prior breast surgery
- Patients who have had prior chest/breast irradiation
Show all 10Show fewer
- Patients with the following diseases which interferes with wound healing: prior hypertrophic scarring/keloids, type I or type II Diabetes Mellitus, autoimmune diseases/collagen vascular diseases
- Patients who are active smokers
- Patients using blood thinners that cannot be stopped
- Patients who have used aspirin within a week of the procedure date
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.
- Conditions
- Skin Scarring
- Being tested
- CO2 Laser Administration
- Keywords
- Skin Scarring, keloids, hypertrophic scars, CO2 laser therapy
- Medical subject headings
- Cicatrix, Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 Laser AdministrationOther
The CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group).
| Study group | Role | What they receive |
|---|---|---|
| Early Laser Therapy | Experimental | a group which will receive laser therapy to one breast incision at the first post-operative visit Receives: Other: CO2 Laser Administration |
| Late Laser Therapy | Experimental | a group which will receive laser therapy to one breast incision 6 weeks after surgery Receives: Other: CO2 Laser Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vancouver Scar Scale Score
Total of score of each measure below:
- Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2
- Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3
- Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5
- Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 >5 mm 3
Measured: 1 Week to Post Laser 1-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start15 Nov 2017
- Primary completion26 Aug 2019 (estimated)
- Study completion26 Aug 2019 (estimated)
Why it stopped: Dr. Hazen is no longer full-time faculty / was not able to find an appropriate PI to take over study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ScarringStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexes Hazen, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306628
- Sponsor's protocol ID
- 17-01153
- Status last verified
- Jan 2020
- First submitted
- 4 Oct 2017
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
- ClinicalTrials.gov ID
- NCT03306628
- Acronym / sponsor ID
- 17-01153
- Conditions
- Skin Scarring
- Keywords
- Skin Scarring, keloids, hypertrophic scars, CO2 laser therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Dr. Hazen is no longer full-time faculty / was not able to find an appropriate PI to take over study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 26 Aug 2019 (estimated)
- Study completion
- 26 Aug 2019 (estimated)
- First posted
- 11 Oct 2017 (actual)
- 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 is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Laser Therapy | Experimental | Other: CO2 Laser Administrationa group which will receive laser therapy to one breast incision at the first post-operative visit |
| Late Laser Therapy | Experimental | Other: CO2 Laser Administrationa group which will receive laser therapy to one breast incision 6 weeks after surgery |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of all ethnic origins will be considered, although certain ethnic groups will be preferentially excluded more than others such as black and South Asian patients due to our exclusion criteria related to darker skin individuals (see below).
- Patients undergoing bilateral breast reduction surgery
Key exclusion criteria (10 listed)
- Males will be excluded from this study as male patients rarely undergo breast reduction surgery. When males do undergo breast reduction surgery for gynecomastia, it is often unilateral, and is performed with several techniques and incision types that are not typical employed during female breast reduction. Thus, for this study, only female patients will be considered (see below).
- Any patient enrolled in this study who shows evidence of delayed wound healing, dehiscence, or post operative infection at the first post operative visit will be excluded
- Patients with darker skin (Fitzpatrick IV and above), which is a well-known contraindication to laser therapy
- Pregnant patients
- Patients who have had prior breast surgery
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 |
|---|---|---|
| CO2 Laser AdministrationThe CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group). | Other | Early Laser Therapy, Late Laser Therapy |
Primary outcome
Change in Vancouver Scar Scale Score
Time frame: 1 Week to Post Laser 1-Year
Total of score of each measure below: * Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 * Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 * Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 * Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 >5 mm 3
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 6 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Alexes Hazen, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 Laser Administration in people with Skin Scarring, run by NYU Langone Health 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 2 inclusion and 10 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 6 Jan 2020. 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?
Change in Vancouver Scar Scale Score (time frame: 1 Week to Post Laser 1-Year). 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 6 Jan 2020.