Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

NCT ID: NCT04202419

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2021-04-26

Brief Summary

This study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).

Detailed Description

Prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions.

Up to 60 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study treatment.

Conditions

Pigmented Skin Lesion

Study Design

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

Study Groups

Single Group

Single Arm: All subjects will undergo treatment of pigmented lesions with a 1940 nm diode laser

Group Type: EXPERIMENTAL

FRAX 1940 nm laser

Intervention Type: DEVICE

A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.

Interventions

FRAX 1940 nm laser

A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or Female

2. Age 21 to 70

3. Fitzpatrick Skin Type I to VI

4. Willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are rated at baseline as moderate or higher per Investigator or study staff

5. Provide signed informed consent to participate in the study

6. Adhere to study treatment and follow-up schedules

7. Willing to have hair removed from the intended treatment area prior to treatment and/or photography

8. Avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (SPF) 30 or greater throughout the duration of the study

9. Adhere to post-treatment care instructions

10. Allow photography of treated areas and to release their use for scientific and/or promotional purposes

Exclusion Criteria

1. Pregnant, planning to become pregnant, or breast feeding during the study

2. Allergy to lidocaine or similar medications

3. Excessively tanned skin in the intended treatment area

4. Open wound or infection in the intended treatment area

5. Tattoo(s) or permanent make-up in the intended treatment area

6. Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy

7. Presence or history of melasma

8. Presence or history of skin cancer within the treatment area

9. History of keloid or hypertrophic scar formation

10. History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication

11. Diagnosed coagulation disorder

12. Immunosuppression disorder

13. Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment

14. Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months

15. Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks

16. Use of oral corticosteroid therapy during the past four (4) weeks

17. Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months

18. Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months

19. Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months

20. Subjects who in the opinion of the Investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Miami Dermatology and Laser Institute

OTHER

Sponsor Role: collaborator

Candela Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill S Waibel, M.D

Role: PRINCIPAL_INVESTIGATOR

Miami Dermatology and Laser Institute

Locations

Miami Dermatology and Laser Institute

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FRX19005

Identifier Type: -

Identifier Source: org_study_id