Benign Pigmented LesionsNCT03409952
Lutronic LaseMD for Treatment of Benign Pigmented Lesions
A study testing LaseMD and DUAL 1927nm Laser and LaseMD in people with Benign Pigmented Lesions, run by CynosureLutronic at 2 sites in United States.
Trial summary
The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benign Pigmented Lesions
- What is being tested?
- LaseMD and DUAL 1927nm Laser and LaseMD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Nov 2017to 25 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to VI.
- Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
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- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing.
- History of keloids or poor wound healing.
- Significant scarring in the area(s) to be treated that would interfere with assessing results.
- Open wounds or lesions in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
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- Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
- History of chronic drug or alcohol abuse.
- History of collagen vascular disease.
- History of autoimmune disease.
- Subjects with implanted pacemaker or defibrillator.
- Subjects with sensitivity or allergy to gold.
- Subjects with sensitivity or allergy to benzocaine, lidocaine, ortetracaine.
- Subjects with photosensitive skin.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Subjects who are pregnant or lactating or anticipate becoming pregnant during the study.
- Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last five years.
- Current user of any nicotine-containing products,e.g.,ecigarettes, Nicorette gum, nicotine patches,etc.
- History of surgical or cosmetic treatments in the area(s) to be treated within the past 6 months.
- History or current use of the following prescription medications:
- Accutane or other systemic retinoids within the past twelve months;
- Topical Retinoids within the past two weeks; and/or
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix).
- Psychiatric drugs that in the investigator's opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermatology, Laser, and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Maryland Dermatology Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030
About this study
Official title: Evaluation of the Lutronic LaseMD System for the Treatment of Benign Pigmented Lesions
The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.
Read the detailed description
This clinical trial is a designed as a prospective, multi-site, non-randomized study of 20 subjects and two treatment groups. Subjects will be enrolled first into Group A, then Group B.
Group A: LaseMD 100 Tip Random Mode vs. DUAL 1927nm (n=12) Group A subjects will receive a split treatment of the décolleté, with LaseMD treatment on one side and DUAL 1927 treatment on the other side. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy.
Group B: LaseMD Optimized Treatments (n=8) Based on safety and efficacy data captured from Group A, subjects in Group B will be treated with the LaseMD optimized treatment parameters for benign pigmented lesions on décolleté, arms, hands, face, and/or neck. A phone follow-up will occur at Day 4 for the assessment of adverse events and expected treatment effects. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy.
- Conditions
- Benign Pigmented Lesions
- Being tested
- LaseMD and DUAL 1927nm Laser, LaseMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaseMD and DUAL 1927nm LaserDevice
Laser treatment of benign pigmented lesion based on photothermolysis whereby the target molecule, the chromophore, absorbs a delivered wavelength of light over a period of time to damage the target while limiting collateral damage to adjacent structures, leading to pigmentary clearance.
LaseMDDevice
Laser treatment of benign pigmented lesion using optimized treatment settings.
| Study group | Role | What they receive |
|---|---|---|
| Group A: LaseMD and DUAL 1927nm Laser | Active comparator | Group A subjects will receive split-side study treatments comparing two devices: LaseMD compared to the DUAL 1927nm laser. Receives: Device: LaseMD and DUAL 1927nm Laser |
| Group B: LaseMD Optimized | Active comparator | Group B subjects will receive LaseMD Optimized Treatments based on Group A treatment data. Receives: Device: LaseMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group A: Evaluation of split-side pigmentary clearance
Blinded assessment of paired post-treatment study photographs conducted by three blinded physician evaluators will compare split-side post-treatment photos. Each assessor will be given identical paired post-treatment photo sets. Each photo's treatment device (LaseMD or DUAL 1927nm) will NOT be marked. Each assessor will compare the Left and Right photo for improvement in benign pigmented lesions using the following definitions:
Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature.
The photo believed to be the most improved photo (Left photo or Right photo) is selected.
Measured: 90 days following the last study treatment
Group B: Percentage of pigmentary clearance in standard photographs
Blinded assessment of paired study photographs conducted by three blinded physician assessors will compare pre- and post-treatment photos. Each assessor will compare paired photo sets for percentage of pigmentary clearance using a score of 0-4: 0=poor (0-24%), 1=fair (25-49%), 2=good (50-74%), 3=excellent (75-95%), 4=complete (95%+) improvement.
Each assessor will be given identical paired pre- and post-treatment photo sets. Each photo's visit interval (pre and post treatment) will NOT be marked. Each assessor will compare Left and Right photo for improvement in benign pigmented lesions using the following definitions:
- Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature.
The photo believed to be the post-treatment photo (Left photo or Right photo) is selected. The assessor will then score the percentage of pigmentary clearance using the 0-4 scale.
Measured: 90 days following the last study treatment
Secondary outcomes (4)
Clinician assessment of overall aesthetic improvement
Overall aesthetic improvement based on completion of the Clinician Global Aesthetic Improvement Scale. Split-side assessments will be conducted for Group A subjects. The scale will be administered based on a live assessment of the subject while referring to the subject's pre-treatment photographs, and based on a comparison of the subject's pre-treatment photographs to the current post-treatment photographs. Aesthetic improvement will be based on the following definitions:
- = Improved: Improvement in appearance from initial condition
- = No Change: The appearance is essentially the same as the original condition.
- = Worse: The appearance is worse than the original condition.
Measured: 28 and 90 days following study treatments
Subject assessment of overall aesthetic improvement
Overall aesthetic improvement based on completion of the Subject Global Aesthetic Improvement Scale. Split-side assessments will be conducted for Group A subjects. Subjects will complete the scale based on a live assessment referring to a hand mirror and their pre-treatment photographs, and based on a comparison of their pre-treatment photographs to the current post-treatment photographs. Aesthetic improvement will be based on the following definitions:
- = Improved: Improvement in appearance from initial condition
- = No Change: The appearance is essentially the same as the original condition.
- = Worse: The appearance is worse than the original condition.
Measured: 28 and 90 days following study treatments
Patient Satisfaction Questionnaire
Based on completion of a Patient Satisfaction Questionnaire while referring to a hand mirror and their pre-treatment photographs. Group A subjects will be asked to complete the questionnaire based on a split-side assessment providing responses specific to each treatment side, i.e., LaseMD treated and DUAL 1927mm treated. Patients will be asked to provides responses to document the level of improvement in skin pigment using the following categories of improvement: 75-100% improved, 50-74% improved, 25-49% improved, 0-24% improved; document any other improvements noted, e.g., skin texture improvement, skin tone improvement, fine lines and wrinkles improvement, etc.; characterize their level of satisfaction based on the following levels of satisfaction: Very Satisfied, Satisfied, Slightly Satisfied; Neither Satisfied or Dissatisfied, Dissatisfied; document if they would recommend each treatment to friends and family members.
Measured: 90 days following study treatment
Treated-related pain
During study treatment, subjects' pain levels will be monitored using a validated Numeric Rating Scale (0-10), with 0 being 'No Pain' and 10 being the 'Worst Possible Pain'. The average pain score for each device will be recorded. Group A will be split-side assessments.
Measured: For the duration of each study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start17 Nov 2017
- Primary completion20 Dec 2018
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Pigmented LesionsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will be enrolled first into Group A, then Group B will be enrolled. Subjects may not be enrolled in both groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari Larson, MBA, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409952
- Sponsor's protocol ID
- L17001
- Status last verified
- Mar 2019
- First submitted
- 17 Jan 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Lutronic LaseMD System for the Treatment of Benign Pigmented Lesions
- ClinicalTrials.gov ID
- NCT03409952
- Acronym / sponsor ID
- L17001
- Conditions
- Benign Pigmented Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 24 Jan 2018 (actual)
- 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 Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.
Detailed description
This clinical trial is a designed as a prospective, multi-site, non-randomized study of 20 subjects and two treatment groups. Subjects will be enrolled first into Group A, then Group B.
Group A: LaseMD 100 Tip Random Mode vs. DUAL 1927nm (n=12) Group A subjects will receive a split treatment of the décolleté, with LaseMD treatment on one side and DUAL 1927 treatment on the other side. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy.
Group B: LaseMD Optimized Treatments (n=8) Based on safety and efficacy data captured from Group A, subjects in Group B will be treated with the LaseMD optimized treatment parameters for benign pigmented lesions on décolleté, arms, hands, face, and/or neck. A phone follow-up will occur at Day 4 for the assessment of adverse events and expected treatment effects. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be enrolled first into Group A, then Group B will be enrolled. Subjects may not be enrolled in both groups.
| Arm | Type | Receives |
|---|---|---|
| Group A: LaseMD and DUAL 1927nm Laser | Active comparator | Device: LaseMD and DUAL 1927nm LaserGroup A subjects will receive split-side study treatments comparing two devices: LaseMD compared to the DUAL 1927nm laser. |
| Group B: LaseMD Optimized | Active comparator | Device: LaseMDGroup B subjects will receive LaseMD Optimized Treatments based on Group A treatment data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to VI.
- Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Key exclusion criteria (27 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- History of keloids or poor wound healing.
- Significant scarring in the area(s) to be treated that would interfere with assessing results.
- Open wounds or lesions in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
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 |
|---|---|---|
| LaseMD and DUAL 1927nm LaserLaser treatment of benign pigmented lesion based on photothermolysis whereby the target molecule, the chromophore, absorbs a delivered wavelength of light over a period of time to damage the target while limiting collateral damage to adjacent structures, leading to pigmentary clearance. | Device | Group A: LaseMD and DUAL 1927nm Laser |
| LaseMDLaser treatment of benign pigmented lesion using optimized treatment settings. | Device | Group B: LaseMD Optimized |
Primary outcome
Group A: Evaluation of split-side pigmentary clearance
Time frame: 90 days following the last study treatment
Blinded assessment of paired post-treatment study photographs conducted by three blinded physician evaluators will compare split-side post-treatment photos. Each assessor will be given identical paired post-treatment photo sets. Each photo's treatment device (LaseMD or DUAL 1927nm) will NOT be marked. Each assessor will compare the Left and Right photo for improvement in benign pigmented lesions using the following definitions: Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature. The photo believed to be the most improved photo (Left photo or Right photo) is selected.
Group B: Percentage of pigmentary clearance in standard photographs
Time frame: 90 days following the last study treatment
Blinded assessment of paired study photographs conducted by three blinded physician assessors will compare pre- and post-treatment photos. Each assessor will compare paired photo sets for percentage of pigmentary clearance using a score of 0-4: 0=poor (0-24%), 1=fair (25-49%), 2=good (50-74%), 3=excellent (75-95%), 4=complete (95%+) improvement. Each assessor will be given identical paired pre- and post-treatment photo sets. Each photo's visit interval (pre and post treatment) will NOT be marked. Each assessor will compare Left and Right photo for improvement in benign pigmented lesions using the following definitions: * Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature. The photo believed to be the post-treatment photo (Left photo or Right photo) is selected. The assessor will then score the percentage of pigmentary clearance using the 0-4 scale.
4 secondary outcomes
Clinician assessment of overall aesthetic improvement
Time frame: 28 and 90 days following study treatments
Subject assessment of overall aesthetic improvement
Time frame: 28 and 90 days following study treatments
Patient Satisfaction Questionnaire
Time frame: 90 days following study treatment
Treated-related pain
Time frame: For the duration of each study 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 13 Mar 2019.
- 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.
Kari Larson, MBA study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LaseMD and DUAL 1927nm Laser and LaseMD in people with Benign Pigmented Lesions, run by CynosureLutronic at 2 sites 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 13 inclusion and 27 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 Mar 2019. 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 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?
Group A: Evaluation of split-side pigmentary clearance (time frame: 90 days following the last study treatment). The study lists 2 primary outcomes in all. 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 Mar 2019.