An interventional study of PicoPlus laser system in Tattoo; Pigmentation, Melasma and Benign Pigmented Lesion, sponsored by LUTRONIC Corporation. Terminated at 4 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by LUTRONIC Corporation · Not applicable, Interventional, and Treatment
This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
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.
Unwanted tattoo that contains single or multi-color ink, and
Exclusion Criteria:
Subjects receiving PicoPlus laser system treatment for unwanted tattoos.
Device: PicoPlus laser system
Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation.
Device: PicoPlus laser system
Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
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%)
Time frame: Up to 6 Months following final study treatment
Subject's Global Assessment of Improvement
Overall aesthetic improvement based on completion of the Subject's Global Assessment of Improvement Scale. Subjects will be asked 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%)
Time frame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Subject Satisfaction
Following the final study treatment, subjects will be asked to rate their level of satisfaction with the laser treatment outcome and the overall laser treatment procedure, using the Subject Satisfaction Assessment Scale and the following definitions: 2 = Extremely Satisfied 1 = Satisfied 0 = Neutral (-1) = Unsatisfied (-2) = Extremely Unsatisfied
Time frame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Blinded Reviewer's Global Assessment of Improvement
Three blinded experienced, non-treating clinicians will independently evaluate pre- and post-treatment photos of each subject, presented randomly. Each reviewer will be asked to determine the temporal order (before and after) of each photo pair, and then rate the degree of tattoo clearing or reduction in benign pigmentation in the post-treatment photo using the following scale: 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%)
Time frame: 3-month (Group B), 6 months (Group A) Post Final treatment
Melasma Area Severity Index (MASI)
Three blinded experienced, non-treating clinicians will independently evaluate pre- and post-treatment photos of each subject, presented randomly, using the MASI. Each of four regions (forehead, right malar region, left malar region and chin) will be assessed based on three variables: percentage of the total area involved (A), darkness (D), and homogeneity (H).
Time frame: 3 Months (Group B), 6 Months (Group A) post final treatment
| Milestone | Group A: PicoPlus for Unwanted Tattoos. | Group B: PicoPlus for Other Dermatological Conditions |
|---|---|---|
| Started | 11 | 28 |
| Completed | 11 | 9 |
| Not completed | 0 | 19 |
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%)
| Participants | Group A: PicoPlus for Unwanted Tattoos. | Group B: PicoPlus for Other Dermatological Conditions |
|---|---|---|
| 3 = Very significant or complete clearing (75-100%) | 1 | 6 |
| 2 = Significant clearing (50-74%) | 2 | 0 |
| 1 = Moderate clearing (25-49%) | 3 | 2 |
| 0 = Mild or no clearing (0-24%) | 0 | 0 |
Overall aesthetic improvement based on completion of the Subject's Global Assessment of Improvement Scale. Subjects will be asked 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%)
| Participants | Group A: PicoPlus for Unwanted Tattoos. | Group B: PicoPlus for Other Dermatological Conditions |
|---|---|---|
| 3 = Very significant or complete clearing (75-100%) | 0 | 6 |
| 2 = Significant clearing (50-74%) | 3 | 3 |
| 1 = Moderate clearing (25-49%) | 3 | 0 |
| 0 = Mild or no clearing (0-24%) | 0 | 0 |
Following the final study treatment, subjects will be asked to rate their level of satisfaction with the laser treatment outcome and the overall laser treatment procedure, using the Subject Satisfaction Assessment Scale and the following definitions: 2 = Extremely Satisfied 1 = Satisfied 0 = Neutral (-1) = Unsatisfied (-2) = Extremely Unsatisfied
No measurements were reported for this outcome.
Three blinded experienced, non-treating clinicians will independently evaluate pre- and post-treatment photos of each subject, presented randomly. Each reviewer will be asked to determine the temporal order (before and after) of each photo pair, and then rate the degree of tattoo clearing or reduction in benign pigmentation in the post-treatment photo using the following scale: 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%)
No measurements were reported for this outcome.
Three blinded experienced, non-treating clinicians will independently evaluate pre- and post-treatment photos of each subject, presented randomly, using the MASI. Each of four regions (forehead, right malar region, left malar region and chin) will be assessed based on three variables: percentage of the total area involved (A), darkness (D), and homogeneity (H).
No measurements were reported for this outcome.
Collected over Adverse events were collected up to 6 months post final treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: PicoPlus for Unwanted Tattoos. | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Group B: PicoPlus for Other Dermatological Conditions | 0/28 (0%) | 0/28 (0%) | 11/28 (39.3%) |
| Event | Group A: PicoPlus for Unwanted Tattoos. | Group B: PicoPlus for Other Dermatological Conditions |
|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 2/11 | 10/28 |
| EdemaSkin and subcutaneous tissue disorders | 1/11 | 7/28 |
| Itching/PruritisSkin and subcutaneous tissue disorders | 2/11 | 5/28 |
| Scabbing/PeelingSkin and subcutaneous tissue disorders | 0/11 | 4/28 |
| Darkening of LesionsSkin and subcutaneous tissue disorders | 1/11 | 3/28 |
| Hypo/Hyper-PigmentationSkin and subcutaneous tissue disorders | 1/11 | 3/28 |
| Bleeding of InkSkin and subcutaneous tissue disorders | 1/11 | 0/28 |
| Heat SensationSkin and subcutaneous tissue disorders | 1/11 | 0/28 |
| Skin BumpsSkin and subcutaneous tissue disorders | 1/11 | 0/28 |
| Welting/Raised Area of EdemaSkin and subcutaneous tissue disorders | 1/11 | 1/28 |
| Age, Continuous(years) | Group A: PicoPlus for Unwanted Tattoos. | Group B: PicoPlus for Other Dermatological Conditions | Total |
|---|---|---|---|
| Mean | 37.8 ± 6.9 | 43.6 ± 15.4 | 38.7 ± 14.8 |
| Sex: Female, Male(Participants) | Group A: PicoPlus for Unwanted Tattoos. | Group B: PicoPlus for Other Dermatological Conditions | Total |
|---|---|---|---|
| Female | 8 | 28 | 36 |
| Male | 3 | 0 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Group A: PicoPlus for Unwanted Tattoos. | Group B: PicoPlus for Other Dermatological Conditions | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 4 | 4 |
| Not Hispanic or Latino | 11 | 15 | 26 |
| Unknown or Not Reported | 0 | 9 | 9 |
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