MelasmaNCT03040089
Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm
A study testing PICO+4 and Neoquine Cream 2% in people with Melasma, run by CynosureLutronic.
Trial summary
This is a prospective, multi-center, split-face, controlled clinical trial that aims to investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. Read more about this study
- Who is it for?
- Ages 19 to 74 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- PICO+4 and Neoquine Cream 2%
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2016to 26 Sep 2016
- 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 19 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females between the ages of 19 and 74
- Has Fitzpatrick Skin Type III-V
- Diagnosed with moderate to severe (GSS ≧ 2) melasma lesions
- Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions
- Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period), and willing to abide by such instructions
- Agreed to the daily use of an over SPF 50 sunblock on their face during the clinical trial period (including the follow-up period), and willing to abide by such instructions
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- Agreed to have their face photographed
- (In case of fertile women) Tested negative in the pregnancy test and agreed to use birth control contraceptives during the clinical trial period
- Oral contraceptives are forbidden as they may influence the results of the clinical study.
- Agreed not to undergo any other procedure on their face during their participation in the clinical trial
- Voluntarily agreed to sign the written consent form and willing to follow the instructions of the study protocol
Who cannot join
- Participated in another medical device or medication clinical trial in the last 3 months, or planning to participate in another trial during this trial
- Received a cosmetic treatment such as laser, light therapy, or surgery in their facial area in the last 6 months, or have a history of filler treatments using collagen, hyaluronic acid, or any other material
- Diagnosed with incurable melisma
- Has a history of allergic reaction to local anesthesia
- Has a history of malignant tumors on their face
- Has skin lesions such as cuts, wounds, or injuries on their face
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- Pregnant or breastfeeding
- Has an infection, dermatitis, or rash on their face
- Currently diagnosed with uncontrolled diabetes or a cardiac disorder such as resistant hypertension
- Currently diagnosed with anticoagulant disease or taking anticoagulants
- Has a history of keloid scarring, hypertrophic scarring, or abnormal would healing
- Has a history of immunodeficiency or intake of immunosuppressants
- Has a history of leukoplakia, eczema, or psoriasis
- Has a history of connective tissue diseases such as systemic lupus erythematosus or scleroderma
- Has a history of convulsive disorder caused by light
- Has a history of diseases irritated by heat on their face (e.g., herpes simplex or herpes zoster)
- Has a history of radiotherapy or anticancer chemotherapy on their face
- Has a history of hormonal therapy in the last 3 months (e.g., estrogen, progesterone, or oral contraceptive)
- Has a history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6 months
- Has excessive facial tanning
- Other subject assessed as inadequate for the clinical trial by the investigators
About this study
Official title: Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Laser Therapy Using 1,064 nm and 595 nm on Patients With Melasma: A Prospective, Multi-center, Split Face, 2% Hydroquinone Cream-controlled Clinical Trial
This is a prospective, multi-center, split-face, controlled clinical trial that aims to investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial will be performed by two Korean institutions on 45 subjects.
- Conditions
- Melasma
- Being tested
- PICO+4, Neoquine Cream 2%
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO+4Device
picosecond, neodymium-doped yttrium aluminum garnet laser
Neoquine Cream 2%Drug
2% hydroquinone cream
| Study group | Role | What they receive |
|---|---|---|
| picosecond laser & 2% hydroquinone cream | Experimental | PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma Receives: Device: PICO+4; Drug: Neoquine Cream 2% |
| 2% hydroquinone cream | Sham comparator | Only Neoquine Cream 2% (2% hydroquinone cream) for melasma Receives: Drug: Neoquine Cream 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of treatment according to RL*I
The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the final treatment.
Measured: Baseline, 1 week after final treatment
Secondary outcomes (3)
Relative skin lightness using the colorimeter(RL*I)
Measured: Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment
mMASI (modified Melasma Area Severity Index) evaluation
Measured: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment
Subject satisfaction (5-point scale questionnaires on subject's satisfaction)
Measured: 1 week and 12 weeks after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start9 Mar 2016
- Primary completion15 Jul 2016
- Study completion26 Sep 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wonserk Kim, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040089
- Sponsor's protocol ID
- LTN-03
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Laser Therapy Using 1,064 nm and 595 nm on Patients With Melasma: A Prospective, Multi-center, Split Face, 2% Hydroquinone Cream-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03040089
- Acronym / sponsor ID
- LTN-03
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 2 Feb 2017 (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 is a prospective, multi-center, split-face, controlled clinical trial that aims to investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial will be performed by two Korean institutions on 45 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| picosecond laser & 2% hydroquinone cream | Experimental | Device: PICO+4, Drug: Neoquine Cream 2%PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma |
| 2% hydroquinone cream | Sham comparator | Drug: Neoquine Cream 2%Only Neoquine Cream 2% (2% hydroquinone cream) for melasma |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Females between the ages of 19 and 74
- Has Fitzpatrick Skin Type III-V
- Diagnosed with moderate to severe (GSS ≧ 2) melasma lesions
- Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions
- Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period), and willing to abide by such instructions
Key exclusion criteria (21 listed)
- Participated in another medical device or medication clinical trial in the last 3 months, or planning to participate in another trial during this trial
- Received a cosmetic treatment such as laser, light therapy, or surgery in their facial area in the last 6 months, or have a history of filler treatments using collagen, hyaluronic acid, or any other material
- Diagnosed with incurable melisma
- Has a history of allergic reaction to local anesthesia
- Has a history of malignant tumors on their face
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 |
|---|---|---|
| PICO+4picosecond, neodymium-doped yttrium aluminum garnet laser | Device | picosecond laser & 2% hydroquinone cream |
| Neoquine Cream 2%2% hydroquinone cream | Drug | 2% hydroquinone cream, picosecond laser & 2% hydroquinone cream |
Primary outcome
Success rate of treatment according to RL*I
Time frame: Baseline, 1 week after final treatment
The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the final treatment.
3 secondary outcomes
Relative skin lightness using the colorimeter(RL*I)
Time frame: Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment
mMASI (modified Melasma Area Severity Index) evaluation
Time frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment
Subject satisfaction (5-point scale questionnaires on subject's satisfaction)
Time frame: 1 week and 12 weeks after the final 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 2 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Wonserk Kim principal investigator
Kangbuk Samsung Hospital
Questions about this trial
What is this clinical trial studying?
A study testing PICO+4 and Neoquine Cream 2% in people with Melasma, run by CynosureLutronic.
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 11 inclusion and 21 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Success rate of treatment according to RL*I (time frame: Baseline, 1 week after final 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 2 Feb 2017.