Clinical trial NCT03415685: Lutronic PicoPlus Exploratory Clinical Trial
Official title: Evaluation of the Lutronic PicoPlus for the Treatment of Dematological Conditions Such as Unwanted Tattoos and Benign Pigmented Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tattoo; Pigmentation
Melasma
Benign Pigmented Lesion
Lead sponsor: LUTRONIC Corporation
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be assigned to one of two treatments group depending on the dermatologic condition to be treated.
Primary purpose: TREATMENT

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.

Detailed description: This pilot clinical trial will evaluate the capability of the Lutronic PicoPlus technology to remove unwanted tattoos and benign pigmented lesions. This trial is designed as a multi-center exploratory, open-label clinical trial comparing each subject's condition before and after treatment. Subjects meeting all entrance criteria will be assigned to Group A for treatment of unwanted tattoos and Group B for treatment of unwanted benign pigmented lesions, melasma, or other skin conditions such as skin rejuvenation. Subjects in each treatment group will receive a series of treatments, e.g., 2-5, and will be asked to complete 1 and 3 month follow-up visit(s) following each treatment to assess treatment efficacy and safety. At investigators' discretion, additional follow-up visits, e.g., at 6 months following treatment, may take place to observe the time course of reactions after treatment and/or assess efficacy. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photos will be obtained at baseline; post-treatment study photos will be obtained at each post-treatment follow-up visit.

Eligibility criteria: Inclusion Criteria:

* 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
* Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria:

* 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.
* Suffering from coagulation disorders or taking prescription anticoagulation medications
* History of keloid scarring, hypertrophic scarring or of abnormal wound healing Any use of medication that is known to increase sensitivity to light according to Investigator's discretion
* Excessive or recent significant tan in areas to be treated or unable/unlikely to refrain from tanning during the study
* Current smoker or history of smoking within 3 months of study participation
* Systemic use of corticosteroid or isotretinoin within 6 months of study participation
* Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus
* Any physical or mental condition including alcohol or drug abuse that in the opinion of the investigator could interfere with subject's suitability for inclusion in study

Primary outcomes:
measure: Investigator's Global Assessment of Improvement
timeFrame: Up to 6 Months following final study treatment
Secondary outcomes:
measure: Subject's Global Assessment of Improvement
timeFrame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
measure: Subject Satisfaction
timeFrame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Other outcomes:
measure: Blinded Reviewer's Global Assessment of Improvement
timeFrame: 3-month (Group B), 6 months (Group A) Post Final treatment
measure: Melasma Area Severity Index (MASI)
timeFrame: 3 Months (Group B), 6 Months (Group A) post final treatment
Locations:
city: Newport Beach
country: United States
facility: Zena Medical
state: California
city: Elmhurst
country: United States
facility: Metro Dermatology
state: New York
city: New York
country: United States
facility: Laser and Skin Surgery Center of New York
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser, and Vein Specialists of the Carolinas
state: North Carolina
Study officials:
affiliation: Sponsor GmbH
name: Kari Larson, MBA
role: STUDY_DIRECTOR
References: