Facial Solar LentiginesNCT02110108
Study for the RevLite Laser System for Facial Solar Lentigines
A study testing Revlite Laser System in people with Facial Solar Lentigines, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Facial Solar Lentigines
- What is being tested?
- Revlite Laser System
- 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
- Mar 2014to Feb 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is a healthy male or female between 18 and 60 years old.
- Is Fitzpatrick Skin types I-III
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
- Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.
Who cannot join
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Is hypersensitive to light exposure OR takes photo sensitized medication.
- Has active or localized systemic infections.
- Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
- Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
Show all 13Show fewer
- Has used Accutane within 6 months prior to enrollment.
- Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- Has a history of keloids.
- Has evidence of compromised wound healing.
- Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines
Read the detailed description
Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.
- Conditions
- Facial Solar Lentigines
- Being tested
- Revlite Laser System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revlite Laser SystemDevice
Revlite Laser System for the Treatment of Facial Solar Lentigines
| Study group | Role | What they receive |
|---|---|---|
| Revlite Laser System- Single Wavelength | Experimental | Revlite Laser System- 1064nm wavelength will be used on half of the face. Receives: Device: Revlite Laser System |
| Revlite Laser System- Dual Wavelength | Experimental | Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face. Receives: Device: Revlite Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.
Measured: 1 month post last treatment
Secondary outcomes (1)
Physician Satisfaction Questionnaire
The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1).
Measured: 1 month post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 Facial Solar LentiginesStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Krantz, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110108
- Sponsor's protocol ID
- CYN14-REV-REJUV-NS
- Status last verified
- Nov 2021
- First submitted
- 8 Apr 2014
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the RevLite Laser System for Facial Solar Lentigines
- ClinicalTrials.gov ID
- NCT02110108
- Acronym / sponsor ID
- CYN14-REV-REJUV-NS
- Conditions
- Facial Solar Lentigines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 4 Feb 2021
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 evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines
Detailed description
Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
| Arm | Type | Receives |
|---|---|---|
| Revlite Laser System- Single Wavelength | Experimental | Device: Revlite Laser SystemRevlite Laser System- 1064nm wavelength will be used on half of the face. |
| Revlite Laser System- Dual Wavelength | Experimental | Device: Revlite Laser SystemRevlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is a healthy male or female between 18 and 60 years old.
- Is Fitzpatrick Skin types I-III
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
- Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.
Key exclusion criteria (13 listed)
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Is hypersensitive to light exposure OR takes photo sensitized medication.
- Has active or localized systemic infections.
- Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
- Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research 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 SystemRevlite Laser System for the Treatment of Facial Solar Lentigines | Device | Revlite Laser System- Dual Wavelength, Revlite Laser System- Single Wavelength |
Primary outcome
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
Time frame: 1 month post last treatment
Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.
1 secondary outcome
Physician Satisfaction Questionnaire
Time frame: 1 month post last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Facial Solar Lentigines
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
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.
Patricia Krantz study director
Cynosure, Inc.
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 System in people with Facial Solar Lentigines, 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 5 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: finished, as of the sponsor's last update on 30 Nov 2021. 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 4 Feb 2021). 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?
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale (time frame: 1 month post last treatment). 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 30 Nov 2021.