Scar PreventionNCT01826942
Scar Prevention Using Fractional Carbon Dioxide Laser Treatment
A study testing Lumenis UltraPulse single fractional CO2 laser treatment thin skin and Single fractional CO2 treatment at surgical area closure procedure on thick skin in people with Scar Prevention, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scar Prevention
- What is being tested?
- Lumenis UltraPulse single fractional CO2 laser treatment thin skin and Single fractional CO2 treatment at surgical area closure procedure on thick skin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Females
- At least 18 and no more than 65 years old
- The surgical area closure in these subjects should be at least 4cm
- Type of surgery scheduled:
- Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure)
- Willing to comply with study dosing and complete the entire course of the study
Who cannot join
- Active bacterial, fungal, or viral infection in the treatment area
- Active cold sores, or herpes in the treatment area
- Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
- History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes.
- History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis)
- Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics)
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- History or presenting with a keloid scar
- Any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes.
- Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator
- Female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding
- Small surgical closure (<4cm)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald L. Moy, M.D.
Beverly Hills, California, 90210
About this study
In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. The investigators will also evaluate the effect of shallow fractional laser treatment versus deep parameters settings. If effective treatments could be performed at time of surgery, this would result in both time and cost saving to the patient and to the healthcare system and will improve patient's self-image post surgeries.
- Conditions
- Scar Prevention
- Being tested
- Lumenis UltraPulse single fractional CO2 laser treatment thin skin, Single fractional CO2 treatment at surgical area closure procedure on thick skin
- Keywords
- Scar prevention, CO2 fractional laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumenis UltraPulse single fractional CO2 laser treatment thin skinDevice
Single fractional CO2 treatment at surgical area closure procedure on thick skinDevice
| Study group | Role | What they receive |
|---|---|---|
| Thin skin | Experimental | Single fractional CO2 treatment at surgical area closure procedure on thin skin Receives: Device: Lumenis UltraPulse single fractional CO2 laser treatment thin skin |
| Thick skin | Experimental | Single fractional CO2 treatment at surgical area closure procedure on thick skin Receives: Device: Single fractional CO2 treatment at surgical area closure procedure on thick skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar appearance by blinded evaluation of photographs of the three month follow-up visit
Measured: three month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Cooperation stooped with PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar PreventionStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826942
- Sponsor's protocol ID
- LUM-ABU-UP-13-01
- Status last verified
- Mar 2014
- First submitted
- 4 Apr 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scar Prevention Using Fractional Carbon Dioxide Laser Treatment
- ClinicalTrials.gov ID
- NCT01826942
- Acronym / sponsor ID
- LUM-ABU-UP-13-01
- Conditions
- Scar Prevention
- Keywords
- Scar prevention, CO2 fractional laser
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cooperation stooped with PI
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Apr 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.
In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. The investigators will also evaluate the effect of shallow fractional laser treatment versus deep parameters settings. If effective treatments could be performed at time of surgery, this would result in both time and cost saving to the patient and to the healthcare system and will improve patient's self-image post surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin skin | Experimental | Device: Lumenis UltraPulse single fractional CO2 laser treatment thin skinSingle fractional CO2 treatment at surgical area closure procedure on thin skin |
| Thick skin | Experimental | Device: Single fractional CO2 treatment at surgical area closure procedure on thick skinSingle fractional CO2 treatment at surgical area closure procedure on thick skin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Females
- At least 18 and no more than 65 years old
- The surgical area closure in these subjects should be at least 4cm
- Type of surgery scheduled:
- Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure)
Key exclusion criteria (13 listed)
- Active bacterial, fungal, or viral infection in the treatment area
- Active cold sores, or herpes in the treatment area
- Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
- History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes.
- History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis)
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 |
|---|---|---|
| Lumenis UltraPulse single fractional CO2 laser treatment thin skin | Device | Thin skin |
| Single fractional CO2 treatment at surgical area closure procedure on thick skin | Device | Thick skin |
Primary outcome
Scar appearance by blinded evaluation of photographs of the three month follow-up visit
Time frame: three month follow-up
Results and safety
The study was stopped early (reason given: Cooperation stooped with PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumenis UltraPulse single fractional CO2 laser treatment thin skin and Single fractional CO2 treatment at surgical area closure procedure on thick skin in people with Scar Prevention, run by Lumenis Be Ltd. 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 26 Mar 2014. 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 stopped early (reason given: Cooperation stooped with PI). Results are not available in the source record.
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?
Scar appearance by blinded evaluation of photographs of the three month follow-up visit (time frame: three month follow-up). 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 26 Mar 2014.