LaseMD System for the Treatment of Melasma

NCT ID: NCT03456674

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2019-06-30

Brief Summary

This study will evaluate the clinical outcomes associated with use of the LaseMD Laser System for the treatment of melasma.

Detailed Description

This clinical trial is a designed as a prospective, multi-site, non-randomized study of 20 subjects. Subjects will receive up to 5 study treatments completed 21 days apart. Phone follow-up will occur at Day 3 following each treatment for the assessment of adverse events and expected treatment effects. Post-treatment follow-up will be completed prior to the next subsequent treatment and at Days 30, 90 and 180 following the last treatment to assess adverse events and expected treatment effects, capture digital images, and assess efficacy.

Conditions

Melasma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LaseMD System

Subjects will receive LaseMD System treatment(s) for treatment of melasma.

Group Type: EXPERIMENTAL

LaseMD System

Intervention Type: DEVICE

A non-invasive fractional thulium laser delivering a wavelength of light energy as a fractionated array of microbeams to be absorbed by and damage the target molecule, a chromophore.

Interventions

LaseMD System

A non-invasive fractional thulium laser delivering a wavelength of light energy as a fractionated array of microbeams to be absorbed by and damage the target molecule, a chromophore.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Female, age 18 years and older.

2. Subject in good health.

3. Fitzpatrick Skin Type I to IV.

4. Moderate to severe melasma (Melasma Severity Scale, score 2 or 3).

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. 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.

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. Inability to understand the protocol or to give informed consent.

2. Presence of an active systemic or local skin disease that may affect wound healing.

3. History of keloids or poor wound healing.

4. Significant scarring in the area(s) to be treated that would interfere with assessing results.

5. Open wounds or lesions in the area(s) to be treated.

6. Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.

7. History of chronic drug or alcohol abuse.

8. History of collagen vascular disease.

9. History of autoimmune disease.

10. Subjects with sensitivity or allergy to pre-treatment medication, EMLA Cream (Lidocaine/Prilocaine).

11. Subjects with sensitivity or allergy to post-treatment cosmeceuticals, Tranexamic Acid and/or coconut.

12. Subjects with photosensitive skin.

13. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.

14. Subjects who are pregnant or lactating or anticipate becoming pregnant during the study.

15. Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.

16. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.

17. Concurrent enrollment in any study involving the use of investigational devices or drugs.

18. Current smoker or history of smoking in the last five years.

19. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.

20. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.

21. History of surgical or cosmetic treatments in the area(s) to be treated within the past 6 months.

22. Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within 4 weeks prior to study participation or during the study.

23. 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.

24. Use of any prescription skin-lightening agent (such as tranexamic acid or hydroquinone), isotretinoin (or other retinoid), photo-sensitizing medication, or corticosteroid within 6 months of and during study participation.

25. 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) within the past two weeks.

4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LUTRONIC Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Larson, MBA

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Laser and Skin Surgery Center of New York

New York, New York, United States

Countries

United States

Other Identifiers

L18002

Identifier Type: -

Identifier Source: org_study_id