Status:
TERMINATED
Lutronic PicoPlus Exploratory Clinical Trial
Lead Sponsor:
LUTRONIC Corporation
Conditions:
Tattoo; Pigmentation
Melasma
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03415685
Start Date
October 12 2017
End Date
October 3 2018
Last Update
December 20 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Zena Medical
Newport Beach, California, United States, 92660
2
Metro Dermatology
Elmhurst, New York, United States, 11373
3
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016
4
Dermatology, Laser, and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207