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

NCT04208100 | Active Not Recruiting FDA Device

• 1 other identifier: L18007
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Pigmented Lesions

Outcome Measures

Primary Outcomes (1)

• Pigmentary Clearance

  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.

  30 days

Secondary Outcomes (2)

• Clinician Global Aesthetic Scale

  30 days

• Subject Global Aesthetic Scale

  30 days

Other Outcomes (2)

• Patient Satisfaction Questionnaire

  30 days

• Pain Scale

  30 days

Interventions

PicoPlus DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (1)

William LoVerme, MD

Billerica, Massachusetts, 01821, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 23, 2019
• Study Start: September 13, 2018
• Primary Completion: September 5, 2019
• Study Completion: March 31, 2020
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

US (1)