CompletedNot Applicable

Lutronic LaseMD for Treatment of Benign Pigmented Lesions

United States20 participantsStarted 2017-11-17

Plain-language summary

The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.

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 VI.
✓. Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
✓. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

✕. 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 consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
✕0. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
✕. Presence of an active systemic or local skin disease that may affect wound healing.

Group A: Evaluation of split-side pigmentary clearance

Timeframe: 90 days following the last study treatment

Group B: Percentage of pigmentary clearance in standard photographs

Timeframe: 90 days following the last study treatment

NCT IDNCT03409952

SponsorCynosureLutronic

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-20

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 VI.
✓. Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
✓. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

✕. 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 consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
✕0. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
✕. Presence of an active systemic or local skin disease that may affect wound healing.