Study stopped due to pivot in company clinical strategy.
Evaluation of the Lutronic PicoPlus for the Treatment of Dematological Conditions Such as Unwanted Tattoos and Benign Pigmented Lesions
Sponsor study identifier
interventional
39
1 country
4
Study Start
October 12, 2017
Actual (reported)Primary Completion
September 6, 2018
Actual (reported)Study Completion
October 3, 2018
Actual (reported)This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 3, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2017
Actual (reported)January 8, 2018
Actual (reported)January 30, 2018
Actual (reported)September 6, 2018
Actual (reported)October 3, 2018
Actual (reported)December 20, 2023
Actual (reported)Investigator's Global Assessment of Improvement
Overall aesthetic improvement based on completion of the Physician's Global Assessment of Improvement Scale. Physician evaluators will review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)
Up to 6 Months following final study treatment
Subject's Global Assessment of Improvement
1 month, 3 Months, 6 Months (Group A Only) post final treatment
Subject Satisfaction
1 month, 3 Months, 6 Months (Group A Only) post final treatment
Blinded Reviewer's Global Assessment of Improvement
3-month (Group B), 6 months (Group A) Post Final treatment
Melasma Area Severity Index (MASI)
3 Months (Group B), 6 Months (Group A) post final treatment
Subjects receiving PicoPlus laser system treatment for unwanted tattoos.
Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation.
Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Zena Medical
Newport Beach, California, 92660, United States
Metro Dermatology
Elmhurst, New York, 11373, United States
Laser and Skin Surgery Center of New York
New York, New York, 10016, United States
Dermatology, Laser, and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207, United States
Early termination of the study led to reduced endpoint evaluation and consistent timing for all the endpoints which were analyzed. It also means that full treatment regimen to fully observe the treatment effectiveness and safety could not be fully completed.
Kari Larson, MBA
Sponsor GmbH
39 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2018
First Posted
January 30, 2018
Study Start
October 12, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 6, 2018
Actual (reported)Study Completion
October 3, 2018
Actual (reported)Last Updated
December 20, 2023
Results First Posted
December 20, 2023
Record last verified: 2023-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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