MelasmaNCT02110134
A Study of the RevLite Laser System for the Treatment of Refractory Mixed Type Melasma
A study testing Revlite Laser System with hydroquinone skin care regimen and Hydroquinone skin care regimen in people with Melasma, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma. 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 Laser System with hydroquinone skin care regimen and Hydroquinone skin care regimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to May 2014
- 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
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
The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma.
- Conditions
- Melasma
- Being tested
- Revlite Laser System with hydroquinone skin care regimen, Hydroquinone skin care regimen
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revlite Laser System with hydroquinone skin care regimenDevice
Revlite Laser System with hydroquinone skin care regimen for the Treatment of Melasma
Hydroquinone skin care regimenOther
Hydroquinone skin care regimen for the Treatment of Melasma
| Study group | Role | What they receive |
|---|---|---|
| Revlite Laser System with Topical | Experimental | Revlite Laser System for the Treatment of Melasma and hydroquinone skin care regimen Receives: Device: Revlite Laser System with hydroquinone skin care regimen |
| Topical | Active comparator | Hydroquinone skin care regimen Receives: Other: Hydroquinone skin care regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Adverse Events Among Patients
Adverse events were collected and reported to test the safety and efficacy of the device.
Measured: From study baseline to completion, approximately 1 year. However, adverse events not resolved by then will be followed up with until they are resolved.
Secondary outcomes (2)
Satisfaction Questionnaire
Physician and subject satisfaction will be ranked on a scale from 1 to 5, where 1 is extremely dissatisfied and 6 is extremely satisfied.
Measured: 1 month post last treatment
Photographic Evaluation using the Global Aesthetic Improvement Scale
Photos will be a taken at baseline and post treatment and then improvement assessed using the Global Aesthetic Improvement Scale. This scale ranges from 0 to 3, where 0 is 0-25% clearance from baseline photograph, 1 is 25-50% clearance from baseline photograph, 2 is 50-75% clearance from baseline photograph, and 3 is 75-100% clearance from baseline photograph.
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 startDec 2013
- Primary completionMay 2014
- Study completionMay 2014
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT02110134
- Sponsor's protocol ID
- CYN13-REV-TOP-MEL-AK
- Status last verified
- Nov 2020
- First submitted
- 8 Apr 2014
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the RevLite Laser System for the Treatment of Refractory Mixed Type Melasma
- ClinicalTrials.gov ID
- NCT02110134
- Acronym / sponsor ID
- CYN13-REV-TOP-MEL-AK
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Apr 2014 (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.
The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revlite Laser System with Topical | Experimental | Device: Revlite Laser System with hydroquinone skin care regimenRevlite Laser System for the Treatment of Melasma and hydroquinone skin care regimen |
| Topical | Active comparator | Other: Hydroquinone skin care regimenHydroquinone skin care regimen |
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
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 Laser System with hydroquinone skin care regimenRevlite Laser System with hydroquinone skin care regimen for the Treatment of Melasma | Device | Revlite Laser System with Topical |
| Hydroquinone skin care regimenHydroquinone skin care regimen for the Treatment of Melasma | Other | Topical |
Primary outcome
Rates of Adverse Events Among Patients
Time frame: From study baseline to completion, approximately 1 year. However, adverse events not resolved by then will be followed up with until they are resolved.
Adverse events were collected and reported to test the safety and efficacy of the device.
2 secondary outcomes
Satisfaction Questionnaire
Time frame: 1 month post last treatment
Photographic Evaluation using the Global Aesthetic Improvement Scale
Time frame: 1 month post last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 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 Laser System with hydroquinone skin care regimen and Hydroquinone skin care regimen 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: finished, as of the sponsor's last update on 17 Nov 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rates of Adverse Events Among Patients (time frame: From study baseline to completion, approximately 1 year. However, adverse events not resolved by then will be followed up with until they are resolved.). 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 Nov 2020.