CompletedNot Applicable

Study for the RevLite Laser System for Facial Solar Lentigines

United States10 participantsStarted 2014-03

Plain-language summary

The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines

Age range18 Years – 60 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.

✓. Is a healthy male or female between 18 and 60 years old.
✓. Is Fitzpatrick Skin types I-III
✓. Is willing to consent to participate in the study.
✓. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
✓. Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.

✕. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
✕. Is hypersensitive to light exposure OR takes photo sensitized medication.
✕. Has active or localized systemic infections.
✕. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
✕. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
✕. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
✕. Has used Accutane within 6 months prior to enrollment.
✕. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.

Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale

Timeframe: 1 month post last treatment

NCT IDNCT02110108

SponsorCynosure, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2020-10-20

Who can participate

Age range18 Years – 60 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.

✓. Is a healthy male or female between 18 and 60 years old.
✓. Is Fitzpatrick Skin types I-III
✓. Is willing to consent to participate in the study.
✓. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
✓. Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.

✕. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
✕. Is hypersensitive to light exposure OR takes photo sensitized medication.
✕. Has active or localized systemic infections.
✕. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
✕. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
✕. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
✕. Has used Accutane within 6 months prior to enrollment.
✕. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.