Active — Not RecruitingNot Applicable

Pilot Evaluation of the Lutronic PicoPlus System for the Treatment of Benign Pigmented Lesions of the Hands

United States41 participantsStarted 2018-09-13

Plain-language summary

Prospective, multi-site, non-randomized study of up to 40 treated subjects; subjects enrolled may be greater than subjects treated.

Age range18 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 18 years and older.
✓. Subject in good health.
✓. Fitzpatrick Skin Type I to IV.
✓. Presence of benign pigmented lesions on hands.
✓. Understands and accepts the obligation not to undergo any other procedures in the treatment area.

✕. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
✕. Postmenopausal for at least 12 months prior to study;
✕. Without a uterus and/or both ovaries; or
✕. Bilateral tubal ligation at least six months prior to study enrollment.
✕. Absence of physical or psychological conditions unacceptable to the investigator.
✕. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
✕. Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, or chemotherapy.
✕. Subjects with a history of photosensitivity or diseases which may be stimulated by light at the wavelengths used, such as history of systemic Lupus Erythematosus, Pophyia, and Epilepsy.

Pigmentary Clearance

Timeframe: 30 days

NCT IDNCT04208100

SponsorCynosureLutronic

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-05

Who can participate

Age range18 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 18 years and older.
✓. Subject in good health.
✓. Fitzpatrick Skin Type I to IV.
✓. Presence of benign pigmented lesions on hands.
✓. Understands and accepts the obligation not to undergo any other procedures in the treatment area.

✕. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
✕. Postmenopausal for at least 12 months prior to study;
✕. Without a uterus and/or both ovaries; or
✕. Bilateral tubal ligation at least six months prior to study enrollment.
✕. Absence of physical or psychological conditions unacceptable to the investigator.
✕. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
✕. Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, or chemotherapy.
✕. Subjects with a history of photosensitivity or diseases which may be stimulated by light at the wavelengths used, such as history of systemic Lupus Erythematosus, Pophyia, and Epilepsy.