Lutronic PicoPlus Exploratory Clinical Trial

NCT03415685 | Terminated Results FDA Device

• 1 other identifier: L16004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

Brief Summary

This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.

Conditions

Tattoo; Pigmentation; Melasma; Benign Pigmented Lesion

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment of Improvement

  Overall aesthetic improvement based on completion of the Physician's Global Assessment of Improvement Scale. Physician evaluators will review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)

  Up to 6 Months following final study treatment

Secondary Outcomes (2)

• Subject's Global Assessment of Improvement

  1 month, 3 Months, 6 Months (Group A Only) post final treatment

• Subject Satisfaction

  1 month, 3 Months, 6 Months (Group A Only) post final treatment

Other Outcomes (2)

• Blinded Reviewer's Global Assessment of Improvement

  3-month (Group B), 6 months (Group A) Post Final treatment

• Melasma Area Severity Index (MASI)

  3 Months (Group B), 6 Months (Group A) post final treatment

Study Arms (2)

Group A: PicoPlus for unwanted tattoos.

ACTIVE COMPARATOR

Subjects receiving PicoPlus laser system treatment for unwanted tattoos.

Device: PicoPlus laser system

Group B: PicoPlus for other dermatological conditions

ACTIVE COMPARATOR

Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation.

Device: PicoPlus laser system

Interventions

PicoPlus laser system DEVICE

Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.

Group A: PicoPlus for unwanted tattoos.; Group B: PicoPlus for other dermatological conditions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female
• Adults between age 18 and 60 years old
• Group A: Fitzpatrick skin type I - VI for unwanted tattoos and Group B: Fitzpatrick Skin Types I - IV for benign pigmented lesions and other conditions
• Unwanted tattoo that contains single or multi-color ink, and
• Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment
• Ability to read, understand, and sign the Informed Consent Form
• Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated

You may not qualify if:

• If receiving treatment for unwanted tattoo: double tattoos (tattoo over tattoo), history of allergic reactions to pigments following tattooing, local anesthetics or topical antibiotics
• If receiving treatment for benign pigmented lesions including melasma: history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), or light-sensitive medication in the last 6 months
• Known cardiovascular disease or cardiac surgery that in the opinion of the investigator would interfere with study treatments
• Previous interventions or treatment with another device in the target area within 6 months of enrollment or during the study
• Pregnant or lactating or planning pregnancy before end of study
• Presence of an active systemic, local skin disease, medication or condition that may affect wound healing or interfere with participation or treatment to the active area.
• Active or recurrent cancer of current chemotherapy or radiation therapy
• History of seizure disorders due to light
• History of vitiligo, eczema, or psoriasis
• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
• History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of seizure disorders due to light.

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (4)

Zena Medical

Newport Beach, California, 92660, United States

Location

Metro Dermatology

Elmhurst, New York, 11373, United States

Location

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Dermatology, Laser, and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination of the study led to reduced endpoint evaluation and consistent timing for all the endpoints which were analyzed. It also means that full treatment regimen to fully observe the treatment effectiveness and safety could not be fully completed.

Results Point of Contact

• Title: Alexander Denis, Global Manager of Clinical Research
• Organization: Lutronic

adenis@lutronic.com

9788959206

Study Officials

• Kari Larson, MBA

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be assigned to one of two treatments group depending on the dermatologic condition to be treated.

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 30, 2018
• Study Start: October 12, 2017
• Primary Completion: September 6, 2018
• Study Completion: October 3, 2018
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)