New Surgical ScarsNCT01030198
Laser Treatment for Fresh Surgical Scars and Mature Scars
A study testing RevLite (Laser Treatment) in people with New Surgical Scars and Scars, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- New Surgical Scars, Scars
- What is being tested?
- RevLite (Laser Treatment)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present [or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration
- Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)
Who cannot join
- Pregnant, lactating, or is planning to become pregnant
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy
- coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
- currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
Show all 17Show fewer
- unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
- Isotretinoin therapy within 6 months
- need to be exposed to artificial tanning devices or excessive sunlight during the trial
- prior treatment with parenteral gold therapy
- does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study
- Diabetes Type 1 or 2
- Lupus, scleroderma or similar immune system disorder
- underlying silicone or other non-absorbable filler in the area of the scar
- phenol chemical peel or dermabrasion to the area of the scar within 3 months
- Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanctuary Medical Aesthetic Center
Boca Raton, Florida, 33431
About this study
Official title: Post-Market, Two-Arm, Single Blind, Controlled Study of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminum Garnet (EO QS Nd:YAG) Laser System for the Treatment of Scars
The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.
- Conditions
- New Surgical Scars, Scars
- Being tested
- RevLite (Laser Treatment)
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevLite (Laser Treatment)Device
| Study group | Role | What they receive |
|---|---|---|
| Fresh surgical scars | Experimental | Treatment of scars Receives: Device: RevLite (Laser Treatment) |
| Mature scars | Experimental | Treatment of scars Receives: Device: RevLite (Laser Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.
Measured: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for New Surgical ScarsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030198
- Sponsor's protocol ID
- C68-08-S
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2009
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market, Two-Arm, Single Blind, Controlled Study of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminum Garnet (EO QS Nd:YAG) Laser System for the Treatment of Scars
- ClinicalTrials.gov ID
- NCT01030198
- Acronym / sponsor ID
- C68-08-S
- Conditions
- New Surgical Scars, Scars
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh surgical scars | Experimental | Device: RevLite (Laser Treatment)Treatment of scars |
| Mature scars | Experimental | Device: RevLite (Laser Treatment)Treatment of scars |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present [or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration
- Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)
Key exclusion criteria (17 listed)
- Pregnant, lactating, or is planning to become pregnant
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy
- coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
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 |
|---|---|---|
| RevLite (Laser Treatment) | Device | Fresh surgical scars, Mature scars |
Primary outcome
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
Time frame: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)
The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 RevLite (Laser Treatment) in people with New Surgical Scars and Scars, run by Cynosure, Inc. 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 17 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 17 Dec 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?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis (time frame: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)). 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 17 Dec 2020.