Nonablative Fractional Diode Laser for Treatment of Pigmented Lesions

Completed · Not applicable

Conditions studied: Pigmented Skin Lesion

In brief

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).

Key facts

Study ID

NCT04202419

Run by

Candela Corporation

People needed

30

Starts

2020-01-09

Expected to finish

2021-04-26

Last updated by the study team

2023-08-07

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or Female
• Age 21 to 70
• Fitzpatrick Skin Type I to VI
• 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
• Provide signed informed consent to participate in the study
• Adhere to study treatment and follow-up schedules
• Willing to have hair removed from the intended treatment area prior to treatment and/or photography
• 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
• Adhere to post-treatment care instructions
• Allow photography of treated areas and to release their use for scientific and/or promotional purposes

You may not qualify if…

• Pregnant, planning to become pregnant, or breast feeding during the study
• Allergy to lidocaine or similar medications
• Excessively tanned skin in the intended treatment area
• Open wound or infection in the intended treatment area
• Tattoo(s) or permanent make-up in the intended treatment area
• Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
• Presence or history of melasma
• Presence or history of skin cancer within the treatment area
• History of keloid or hypertrophic scar formation
• History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
• Diagnosed coagulation disorder
• Immunosuppression disorder
• Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
• Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
• Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
• Use of oral corticosteroid therapy during the past four (4) weeks
• Prior treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past three (3) months
• Prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months
• Prior injectable toxins (e.g. Botox) in the intended treatment area within the past three (3) months
• 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

Where it is running

• Miami Dermatology and Laser Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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