Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

Candela Corporation

Status: Completed

Conditions: Pigmented Skin Lesion

Treatments: Device: FRAX 1940 nm laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04202419

FRX19005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Group

Experimental group

Description:

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

Treatment:

Device: FRAX 1940 nm laser