MelasmaNCT01745224
Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma
A study testing Revlite Q switched Nd:YAG and Trivantage Q switched Nd: YAG in people with Melasma, run by Cynosure, Inc. at 1 site in United States.
Trial summary
This proof of concept study will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q Switched Nd: YAG Laser vs. Alex TriVantage Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- Revlite Q switched Nd:YAG and Trivantage Q switched Nd: YAG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Fitzpatrick Skin Type III-VI
- Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
- Subjects who are over the age of 18 years of age
- The subject is willing and able to comply with study instructions and return to the clinic for required visits.
- The subject's melasma has persisted for greater than 6 months and has failed to respond to conventional treatment with hydroquinone cream or other topical lightening agents.
Who cannot join
- The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
- The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
- The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- The subject is 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 prior to entering this study.
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- The subject has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present.
- The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- The subject has Diabetes Type 1 or 2.
- The subject has a sensitivity to hydroquinone or Retin-A.
- The subject has evidence of a compromised immune system or hepatitis.
- Has had microdermabrasion in past 3 months, other laser or Intense Pulsed Light treatment or chemical peels to the face in past 6 months, injectable fillers, topical retinoids, over-the-counter anti-aging products past 2 weeks.
- Has a history of keloids or hypertrophic scarring
- Has permanent make-up and/or is unwilling to refrain from using semi-permanent cosmetics during study
Trial locations and contacts
1 site in 1 country.
About this study
This proof of concept study will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q Switched Nd: YAG Laser vs. Alex TriVantage
- Conditions
- Melasma
- Being tested
- Revlite Q switched Nd:YAG, Trivantage Q switched Nd: YAG
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revlite Q switched Nd:YAGDevice
Revlite Q switched Nd:YAG 1064nm
Trivantage Q switched Nd: YAGDevice
Trivantage Q switched Nd: YAG 1064nm
| Study group | Role | What they receive |
|---|---|---|
| Revlite Q switched Nd:YAG laser | Experimental | Revlite Q switched Nd:YAG laser 1064 nm Receives: Device: Revlite Q switched Nd:YAG; Device: Trivantage Q switched Nd: YAG |
| TriVantage Q switched Nd:YAG laser | Experimental | TriVantage Q switched Nd:YAG laser 1064nm Receives: Device: Revlite Q switched Nd:YAG; Device: Trivantage Q switched Nd: YAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Melasma Determined by Physician
The Global Aesthetic Improvement scale was used to determine the amount of improvement. This scale ranges from 1 to 5, where 1 is very much improved, 2 is much improved, 3 is improved, 4 is no change, and 5 is worsened.
Measured: 3 months post last treatment
Secondary outcomes (1)
Universal Pain Scale for Subject Tolerability
The subject pain tolerability was assessed using the Universal Pain Scale. This scale ranges from 0 (no pain) to 10 (worst pain possible).
Measured: 3 months 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 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: The study stopped because patient enrollment requirements were not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies 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
- This was a comparative study where the device was used outside of the recommended treatment usage. It was used to assess the Revlite device for feasibility and not health outcomes.
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT01745224
- Sponsor's protocol ID
- CYN12-REV-TRI-AK
- Status last verified
- Dec 2020
- First submitted
- 6 Dec 2012
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma
- ClinicalTrials.gov ID
- NCT01745224
- Acronym / sponsor ID
- CYN12-REV-TRI-AK
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped because patient enrollment requirements were not met.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Dec 2012 (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 proof of concept study will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q Switched Nd: YAG Laser vs. Alex TriVantage
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a comparative study where the device was used outside of the recommended treatment usage. It was used to assess the Revlite device for feasibility and not health outcomes.
| Arm | Type | Receives |
|---|---|---|
| Revlite Q switched Nd:YAG laser | Experimental | Device: Revlite Q switched Nd:YAG, Device: Trivantage Q switched Nd: YAGRevlite Q switched Nd:YAG laser 1064 nm |
| TriVantage Q switched Nd:YAG laser | Experimental | Device: Revlite Q switched Nd:YAG, Device: Trivantage Q switched Nd: YAGTriVantage Q switched Nd:YAG laser 1064nm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with Fitzpatrick Skin Type III-VI
- Subjects with mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp.
- Subjects who are over the age of 18 years of age
- The subject is willing and able to comply with study instructions and return to the clinic for required visits.
- The subject's melasma has persisted for greater than 6 months and has failed to respond to conventional treatment with hydroquinone cream or other topical lightening agents.
Key exclusion criteria (15 listed)
- The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- The subject has a history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
- The subject has any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy.
- The subject has an uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy).
- The subject 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 Q switched Nd:YAGRevlite Q switched Nd:YAG 1064nm | Device | Revlite Q switched Nd:YAG laser, TriVantage Q switched Nd:YAG laser |
| Trivantage Q switched Nd: YAGTrivantage Q switched Nd: YAG 1064nm | Device | Revlite Q switched Nd:YAG laser, TriVantage Q switched Nd:YAG laser |
Primary outcome
Changes in Melasma Determined by Physician
Time frame: 3 months post last treatment
The Global Aesthetic Improvement scale was used to determine the amount of improvement. This scale ranges from 1 to 5, where 1 is very much improved, 2 is much improved, 3 is improved, 4 is no change, and 5 is worsened.
1 secondary outcome
Universal Pain Scale for Subject Tolerability
Time frame: 3 months post last treatment
Results and safety
The study was stopped early (reason given: The study stopped because patient enrollment requirements were not met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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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.
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 Q switched Nd:YAG and Trivantage Q switched Nd: YAG in people with Melasma, 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 15 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 4 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?
The study was stopped early (reason given: The study stopped because patient enrollment requirements were not met.). 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?
Changes in Melasma Determined by Physician (time frame: 3 months 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 4 Dec 2020; AzTrials last refreshed its copy on 31 Oct 2026.