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

Running, not enrolling · Not applicable

Conditions studied: Benign Pigmented Lesions

In brief

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

Key facts

Study ID

NCT04208100

Run by

CynosureLutronic

People needed

41

Starts

2018-09-13

Expected to finish

2020-03-31

Last updated by the study team

2019-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
• 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.

You may not qualify if…

• 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.
• History of chronic drug or alcohol abuse.
• Inability to understand the protocol or to give informed consent.
• Subjects with a history of skin cancer or current condition of any other type of cancer or pre-malignant moles.
• Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
• History of keloid formation.
• Subjects with tattoos on the backs of the hands in the treatment area.
• History of surgical or cosmetic treatments in exposure area within the past six months.
• History of tanning or use of self-tanners in the past 4 weeks.
• History of treatments that may irritate the skin in the treatment area such as depilatories, harsh chemicals, etc.) in the past 2 weeks.

Where it is running

• William LoVerme, MD — Billerica, Massachusetts, United States

Full record on ClinicalTrials.gov

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