MelasmaNCT02385994
A Prospective Multi-Center Study Using Laser for the Treatment of Melasma and Lentigines in Asian Skin
A study testing enLighten Laser in people with Melasma and Lentigines, run by Cutera Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of melasma and lentigines on the face in Asian skin. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Melasma, Lentigines
- What is being tested?
- enLighten Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2015to Jan 2017
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or Male, 20 to 75 years of age (inclusive).
- Fitzpatrick Skin Type III - V.
- Has moderate to severe melasma (any type), OR any type of lentigo/lentigines ≥ 6mm in diameter, and desires laser treatment.
- Willing to refrain from using topical and systemic corticosteroids or retinoids, and topical or systemic prescription skin-lightening medications, except permitted topical steroid use as directed by study doctor.
- Willing to maintain consistent skin care regimen on the treatment area for the duration of the study, including the follow-up period.
- Must be able to read, understand and sign the Informed Consent Form.
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- Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
- Willing to have digital photographs taken of the treatment area.
- Agree not to undergo any other procedure(s) in the treatment area during the study.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
Who cannot join
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
- Prior injection of collagen, hyaluronic acid filler or any other dermal filler in the target area within 6 months of study participation.
- Has mild melasma OR facial lentigo/lentigines less than 6mm in diameter.
- History of refractory melasma.
- History of allergy to local anesthetics, as applicable.
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- History of malignant tumors in the target area.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds.
- Pregnant and/or breastfeeding.
- Having an infection, dermatitis or a rash in the treatment area.
- Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- Suffering from coagulation disorders or taking prescription anticoagulation medications.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- History of vitiligo, eczema, or psoriasis.
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- History of seizure disorders due to light.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- History of hormone treatment, such as estrogen, progesterone and/or oral contraceptives, initiated within 3 months of study participation, or planning to discontinue hormone therapy during the study, as applicable.
- Systemic use of any prescription skin-lightening agent (such as tranexamic acid), isotretinoin (or other retinoid), photo-sensitizing medication, or corticosteroid within 6 months of and during study participation, except if the subject undergoes a 6-month wash-out period of excluded systemic prescriptions prior to first laser treatment.
- Topical use of any prescription skin-lightening agent (such as hydroquinone), isotretinoin (or other retinoid), photo-sensitizing medication, or corticosteroid on the treatment area within 6 months of and during study participation, except permitted topical steroid use as directed by study doctor and if subject undergoes a 6-month wash-out period of excluded topical prescriptions prior to first laser treatment.
- Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective Multi-Center Study of a Novel Dual-Wavelength, Dual-Pulse Duration Laser for the Treatment of Melasma and Lentigines in Asian Skin
The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of melasma and lentigines on the face in Asian skin.
Read the detailed description
This is a multi-center prospective, 2 cohort study in 80 male or female subjects of Asian-descent, who desire laser treatment for moderate to severe melasma (all types) or lentigines (all types) located on the face. Forty subjects will be enrolled in cohort 1 and randomized to either treatment or control arm. Forty subjects will be enrolled for treatment of facial lentigines in cohort 2.
- Conditions
- Melasma, Lentigines
- Being tested
- enLighten Laser
- Medical subject headings
- Melanosis, Lentigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enLighten LaserDevice
enLighten Laser treatment with dual-pulse width and dual-wavelength
| Study group | Role | What they receive |
|---|---|---|
| enLighten Laser Treatment | Experimental | Melasma, Cohort I or Lentigines, Cohort II will be treated with dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser. Receives: Device: enLighten Laser |
| Control | No intervention | Melasma subjects randomized to non-treatment will receive no treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Assessment measured by 5-point improvement scale
Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
Measured: 12 weeks
Secondary outcomes (4)
Subject Assessment measured by 5-point improvement scale
Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
Measured: 12 weeks
Melasma Subject's MASI Improvement
Change in mean Melasma Area and Severity Index (MASI) value at 3 months post-final treatment as compared to baseline
Measured: 12 weeks
Relative Melanin Index
Change in mean relative Melanin Index (MI) value at 3 months post-final treatment as compared to baseline as assessed by mexameter measurements
Measured: 12 weeks
Pain and Adverse Events
Incidence and severity of adverse device effects during the study period, including subject pain level during laser treatment
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Hin-Lee Chan, M.D., Ph.D, Principal investigator, Hong Kong Dermatology and Laser CentreKei Negishi, M.D., Ph.D, Principal investigator, Tokyo Women's Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385994
- Sponsor's protocol ID
- C-14-EN01
- Status last verified
- Jan 2017
- First submitted
- 3 Mar 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Study of a Novel Dual-Wavelength, Dual-Pulse Duration Laser for the Treatment of Melasma and Lentigines in Asian Skin
- ClinicalTrials.gov ID
- NCT02385994
- Acronym / sponsor ID
- C-14-EN01
- Conditions
- Melasma, Lentigines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Mar 2015 (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 investigation is to evaluate safety and efficacy of the Cutera enlighten dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of melasma and lentigines on the face in Asian skin.
Detailed description
This is a multi-center prospective, 2 cohort study in 80 male or female subjects of Asian-descent, who desire laser treatment for moderate to severe melasma (all types) or lentigines (all types) located on the face. Forty subjects will be enrolled in cohort 1 and randomized to either treatment or control arm. Forty subjects will be enrolled for treatment of facial lentigines in cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enLighten Laser Treatment | Experimental | Device: enLighten LaserMelasma, Cohort I or Lentigines, Cohort II will be treated with dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser. |
| Control | No intervention | –Melasma subjects randomized to non-treatment will receive no treatments. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or Male, 20 to 75 years of age (inclusive).
- Fitzpatrick Skin Type III - V.
- Has moderate to severe melasma (any type), OR any type of lentigo/lentigines ≥ 6mm in diameter, and desires laser treatment.
- Willing to refrain from using topical and systemic corticosteroids or retinoids, and topical or systemic prescription skin-lightening medications, except permitted topical steroid use as directed by study doctor.
- Willing to maintain consistent skin care regimen on the treatment area for the duration of the study, including the follow-up period.
Key exclusion criteria (26 listed)
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
- Prior injection of collagen, hyaluronic acid filler or any other dermal filler in the target area within 6 months of study participation.
- Has mild melasma OR facial lentigo/lentigines less than 6mm in diameter.
- History of refractory melasma.
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 |
|---|---|---|
| enLighten LaserenLighten Laser treatment with dual-pulse width and dual-wavelength | Device | enLighten Laser Treatment |
Primary outcome
Investigator Assessment measured by 5-point improvement scale
Time frame: 12 weeks
Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
4 secondary outcomes
Subject Assessment measured by 5-point improvement scale
Time frame: 12 weeks
Melasma Subject's MASI Improvement
Time frame: 12 weeks
Relative Melanin Index
Time frame: 12 weeks
Pain and Adverse Events
Time frame: Day 1
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 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Henry Hin-Lee Chan, M.D., Ph.D principal investigator
Hong Kong Dermatology and Laser Centre
Kei Negishi, M.D., Ph.D principal investigator
Tokyo Women's Medical University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enLighten Laser in people with Melasma and Lentigines, run by Cutera Inc. at 2 sites in 2 countries.
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 26 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Japan. 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?
Investigator Assessment measured by 5-point improvement scale (time frame: 12 weeks). 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 31 Jan 2017.