Refractory Mixed Type MelasmaNCT01335581
Study of Laser Treatment of Melasma
A study testing Q-Switched Nd:YAG Laser (RevLite) and Retin-A and microdermabrasion in people with Refractory Mixed Type Melasma, run by ConBio, a Cynosure Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Mixed Type Melasma
- What is being tested?
- Q-Switched Nd:YAG Laser (RevLite) and Retin-A and microdermabrasion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type III-VI
- mixed (epidermal and dermal) melasma diagnosed by Wood's Lamp exam
- age 18 or older
- melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
- written and verbal informed consent
- willing and able to comply with study instructions and return to the clinic for required visits
Who cannot join
- Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
- history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
- any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
- uncorrected coagulation defect or is 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 this research study
- currently enrolled in an investigational drug or device trial, or has received an investigational drug or has been treated with an investigational device within 30 days prior to entering this study
Show all 14Show fewer
- inability to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- unreliability for the study (this includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits)
- use of photosensitizing drugs within a timeframe where photosensitization from these drugs may still be present
- need to be exposed to artificial tanning devices or excessive sunlight during the trial
- Diabetes Type I or II
- sensitivity to hydroquinone or Retin-A
- evidence of a compromised immune system or hepatitis
- use of bleaching creams or retinoids within the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Laser and Skin Care
New York, New York, 10028
About this study
Official title: A Study of the RevLite Q-Switched Nd:YAG Laser System With Smart Infinite (SI) Handpiece for the Treatment of Refractory Mixed Type Melasma
The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.
- Conditions
- Refractory Mixed Type Melasma
- Being tested
- Q-Switched Nd:YAG Laser (RevLite), Retin-A and microdermabrasion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-Switched Nd:YAG Laser (RevLite)Device
Laser treatment added to a microdermabrasion and topical lightening agent regimen
Retin-A and microdermabrasionDrug
Microdermabrasion and topical lightening agent regimen
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Laser treatment and microdermabrasion and topical lightening agent regimen Receives: Device: Q-Switched Nd:YAG Laser (RevLite); Drug: Retin-A and microdermabrasion |
| Control | Active comparator | Microdermabrasion and topical lightening agent regimen Receives: Drug: Retin-A and microdermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up
The severity of the melasma is assessed based on a photographic scale. The scale ranges from 0 to 48, with 48 being the most severe. A decrease in the MASI score from the baseline to the follow up corresponds with decreasing severity.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
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 Refractory Mixed Type 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConBio, a Cynosure Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arielle Kauvar, MD, Principal investigator, New York Laser and Skin Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335581
- Sponsor's protocol ID
- C69-10-M
- Status last verified
- Jan 2022
- First submitted
- 12 Apr 2011
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the RevLite Q-Switched Nd:YAG Laser System With Smart Infinite (SI) Handpiece for the Treatment of Refractory Mixed Type Melasma
- ClinicalTrials.gov ID
- NCT01335581
- Acronym / sponsor ID
- C69-10-M
- Conditions
- Refractory Mixed Type Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ConBio, a Cynosure CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 28 Dec 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 evaluate the RevLite laser in the treatment of refractory mixed type melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: Q-Switched Nd:YAG Laser (RevLite), Drug: Retin-A and microdermabrasionLaser treatment and microdermabrasion and topical lightening agent regimen |
| Control | Active comparator | Drug: Retin-A and microdermabrasionMicrodermabrasion and topical lightening agent regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fitzpatrick Skin Type III-VI
- mixed (epidermal and dermal) melasma diagnosed by Wood's Lamp exam
- age 18 or older
- melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
- written and verbal informed consent
Key exclusion criteria (14 listed)
- Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
- history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
- any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
- uncorrected coagulation defect or is 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 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 |
|---|---|---|
| Q-Switched Nd:YAG Laser (RevLite)Laser treatment added to a microdermabrasion and topical lightening agent regimen | Device | Laser treatment |
| Retin-A and microdermabrasionMicrodermabrasion and topical lightening agent regimen | Drug | Control, Laser treatment |
Primary outcome
Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up
Time frame: 3 Months
The severity of the melasma is assessed based on a photographic scale. The scale ranges from 0 to 48, with 48 being the most severe. A decrease in the MASI score from the baseline to the follow up corresponds with decreasing severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- 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.
Arielle Kauvar, MD principal investigator
New York Laser and Skin Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q-Switched Nd:YAG Laser (RevLite) and Retin-A and microdermabrasion in people with Refractory Mixed Type Melasma, run by ConBio, a Cynosure Company 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 14 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 13 Jan 2022. 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 28 Dec 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?
Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up (time frame: 3 Months). 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 13 Jan 2022.