Lutronic PicoPlus Exploratory Clinical Trial

Stopped early · Not applicable

Conditions studied: Tattoo; Pigmentation, Melasma, Benign Pigmented Lesion

In brief

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

Key facts

Study ID

NCT03415685

Run by

CynosureLutronic

People needed

39

Starts

2017-10-12

Expected to finish

2018-10-03

Last updated by the study team

2023-12-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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
• 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

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.
• 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

Where it is running

• Zena Medical — Newport Beach, California, United States
• Metro Dermatology — Elmhurst, New York, United States
• Laser and Skin Surgery Center of New York — New York, New York, United States
• Dermatology, Laser, and Vein Specialists of the Carolinas — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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