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

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

Study Overview

• Status: Unknown
• Conditions: Benign Pigmented Lesions
• Intervention / Treatment: Device: PicoPlus

Detailed Description

Subjects will be enrolled to ensure a minimum number of subjects by skin type participate in the study as follows: FST I-II, at least 5 subjects; FST III, at least 10 subjects; FST IV, at least 5 subjects. Additionally, up to 20 training subjects will be enrolled that will be excluded from efficacy analysis, but will be included in safety analysis.

Standardized baseline and follow-up images will be taken using the sites' preferred camera system. No pre-treatment medication prior to study treatment.

Phase I: Study subjects will receive up to three treatments with the PicoPlus with the 595nm on one hand and the 660nm on the other hand. Subjects will receive the same wavelength for all treatments on each specific hand; treatments will alternate by subjects between the left side getting treated with the 595nm and the right side getting treated with the 660nm depending on enrollment. Treatments will be 30+7 days apart up to three treatments until desired clearance has been achieved.

Phase II: Up to 2 balancing treatments may be done if needed based on the investigator's discretion to achieve equal clearance on each hand utilizing the wavelength of the investigator's choice. Phase II will not be considered for efficacy endpoints.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Billerica, Massachusetts, United States, 01821
      • William LoVerme, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Global Aesthetic Scale	The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a Clinician Global Aesthetic Improvement Scale assessing overall aesthetic improvement by wavelength at the 30-day visit following the last treatment visit for Phase I of the study. Scale ranging 1-Very Much Improved and 5-Worse.	30 days
Subject Global Aesthetic Scale	2. The subject will complete a SGAIS assessing overall aesthetic improvement by wavelength at the 30-day visit following the last treatment visit for Phase I of the study. Scale Ranging 1-Very Much Improved and 5-Worse.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Questionnaire	The subject will complete a Patient Satisfaction Questionnaire by wavelength at the 30-day visit following the last treatment visit for Phase I of the study. There are 4 questions.	30 days
Pain Scale	During all study treatments, the subject's pain levels will be monitored using a validated Numeric Rating Scale ranging from 0-10. The maximum and average pain score will be recorded by wavelength.	30 days

Collaborators and Investigators

• Sponsor: LUTRONIC Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): September 5, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: L18007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No