NCT04202419

Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Treatment of Pigmented Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Candela Corporation · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-01-09
• Primary completion: 2021-04-26
• Completion: 2021-04-26
• First posted: 2019-12-17
• Last updated: 2023-08-07
• Results posted: 2023-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study