Clinical trial NCT03409952: Lutronic LaseMD for Treatment of Benign Pigmented Lesions
Official title: Evaluation of the Lutronic LaseMD System for the Treatment of Benign Pigmented Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Pigmented Lesions
Lead sponsor: LUTRONIC Corporation
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects will be enrolled first into Group A, then Group B will be enrolled. Subjects may not be enrolled in both groups.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female, age 18 years and older.
2. Subject in good health.
3. Fitzpatrick Skin Type I to VI.
4. Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
5. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
6. 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.
7. 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:

   1. Postmenopausal for at least 12 months prior to study;
   2. Without a uterus and/or both ovaries; or
   3. Bilateral tubal ligation at least six months prior to study enrollment.
8. Absence of physical or psychological conditions unacceptable to the investigator.
9. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
10. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion Criteria:

1. Presence of an active systemic or local skin disease that may affect wound healing.
2. History of keloids or poor wound healing.
3. Significant scarring in the area(s) to be treated that would interfere with assessing results.
4. Open wounds or lesions in the area(s) to be treated.
5. Inability to understand the protocol or to give informed consent.
6. Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
7. Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
8. History of chronic drug or alcohol abuse.
9. History of collagen vascular disease.
10. History of autoimmune disease.
11. Subjects with implanted pacemaker or defibrillator.
12. Subjects with sensitivity or allergy to gold.
13. Subjects with sensitivity or allergy to benzocaine, lidocaine, ortetracaine.
14. Subjects with photosensitive skin.
15. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
16. Subjects who are pregnant or lactating or anticipate becoming pregnant during the study.
17. Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.
18. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
19. Concurrent enrollment in any study involving the use of investigational devices or drugs.
20. Current smoker or history of smoking in the last five years.
21. Current user of any nicotine-containing products,e.g.,ecigarettes, Nicorette gum, nicotine patches,etc.
22. History of surgical or cosmetic treatments in the area(s) to be treated within the past 6 months.
23. History or current use of the following prescription medications:

    1. Accutane or other systemic retinoids within the past twelve months;
    2. Topical Retinoids within the past two weeks; and/or
    3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix).
24. Psychiatric drugs that in the investigator's opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Primary outcomes:
measure: Group A: Evaluation of split-side pigmentary clearance
timeFrame: 90 days following the last study treatment
measure: Group B: Percentage of pigmentary clearance in standard photographs
timeFrame: 90 days following the last study treatment
Secondary outcomes:
measure: Clinician assessment of overall aesthetic improvement
timeFrame: 28 and 90 days following study treatments
measure: Subject assessment of overall aesthetic improvement
timeFrame: 28 and 90 days following study treatments
measure: Patient Satisfaction Questionnaire
timeFrame: 90 days following study treatment
measure: Treated-related pain
timeFrame: For the duration of each study treatment
Other outcomes:
Locations:
city: Hunt Valley
country: United States
facility: Maryland Dermatology Laser, Skin & Vein Institute
state: Maryland
city: Charlotte
country: United States
facility: Dermatology, Laser, and Vein Specialists of the Carolinas
state: North Carolina
Study officials:
affiliation: Sponsor GmbH
name: Kari Larson, MBA
role: STUDY_DIRECTOR
References: