CompletedNot Applicable

Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions

United States26 participantsStarted 2019-09-18

Plain-language summary

This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.

Age range21 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or Female
✓. Age 21 to 70
✓. Fitzpatrick Skin Type I to V
✓. Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
✓. Presence of pigmented lesions to be treated off the face must be 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

✕. 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(s)

Pigmented Lesion Improvement by Blinded Evaluation

Timeframe: 1 month follow-up post treatment series, where treatment could last up to 10 weeks from baseline

NCT IDNCT04203745

SponsorCandela Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-30

Results submitted2023-04-10

Who can participate

Age range21 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or Female
✓. Age 21 to 70
✓. Fitzpatrick Skin Type I to V
✓. Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
✓. Presence of pigmented lesions to be treated off the face must be 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

✕. 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(s)