PicoPlus: The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 595nm and 660nm wavelengths of the Lutronic PicoPlus Laser system are used for the treatment of benign pigmented lesions.
Study summary
Prospective, multi-site, non-randomized study of up to 40 treated subjects; subjects enrolled may be greater than subjects treated.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Male or female, age 18 years and older.
2. Subject in good health.
3. Fitzpatrick Skin Type I to IV.
4. Presence of benign pigmented lesions on hands.
5. Understands and accepts the obligation not to undergo any other procedures in the treatment area.
6. 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.
7. 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:
1. Postmenopausal for at least 12 months prior to study;
2. Without a uterus and/or both ovaries; or
3. Bilateral tubal ligation at least six months prior to study enrollment.
8. Absence of physical or psychological conditions unacceptable to the investigator.
9. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Exclusion Criteria:
1. Healing disorders such as those caused by diabetes mellitus, connective tissue disease, radiation therapy, or chemotherapy.
2. 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.
3. History of chronic drug or alcohol abuse.
4. Inability to understand the protocol or to give informed consent.
5. Subjects with a history of skin cancer or current condition of any other type of cancer or pre-malignant moles.
6. Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
7. History of keloid formation.
8. Subjects with tattoos on the backs of the hands in the treatment area.
9. History of surgical or cosmetic treatments in exposure area within the past six months.
10. History of tanning or use of self-tanners in the past 4 weeks.
11. History of treatments that may irritate the skin in the treatment area such as depilatories, harsh chemicals, etc.) in the past 2 weeks.
\-
Primary outcome measure(s)
Pigmentary Clearance — 30 days Percentage of pigmentary clearance by each wavelength in standard photographs from the 30-day visit post the last treatment in Phase I of the study using a score of 0-4, representing poor 0-24%, fair 25-49%, good 50-74%, excellent 75-95%, and complete 95%+ improvement was given at the day 30 follow-up visit post the last treatment as determined by three blinded physician evaluators comparing the baseline vs 30-day follow-up visit photographs.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.