NCT03415685

Lutronic PicoPlus Exploratory Clinical Trial

Evaluation of the Lutronic PicoPlus for the Treatment of Dematological Conditions Such as Unwanted Tattoos and Benign Pigmented Lesions

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tattoo; Pigmentation
• Melasma
• Benign Pigmented Lesion

Interventions

Type	Name	Description
DEVICE	PicoPlus laser system	Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.

Timeline

• Start date: 2017-10-12
• Primary completion: 2018-09-06
• Completion: 2018-10-03
• First posted: 2018-01-30
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study