Lutronic PicoPlus Exploratory Clinical Trial

Melasma Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Benign Pigmented Lesion
• Melanosis
• Melasma
• Tattoo; Pigmentation

• NCT number: NCT03415685
• Study type: Interventional
• Source: LUTRONIC Corporation
• Status: Terminated
• Phase: N/A
• Start date: October 12, 2017
• Completion date: October 3, 2018