Adults 18 to 60, any sex, with Tattoo; Pigmentation or Melasma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Investigator's Global Assessment of ImprovementPrimary· Up to 6 Months following final study treatment
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%)
Group
Value
95% CI
Group A: PicoPlus for Unwanted Tattoos.
1
Group B: PicoPlus for Other Dermatological Conditions
6
Group A: PicoPlus for Unwanted Tattoos.
2
Group B: PicoPlus for Other Dermatological Conditions
0
Group A: PicoPlus for Unwanted Tattoos.
3
Group B: PicoPlus for Other Dermatological Conditions
2
Group A: PicoPlus for Unwanted Tattoos.
0
Group B: PicoPlus for Other Dermatological Conditions
0
Subject's Global Assessment of ImprovementSecondary· 1 month, 3 Months, 6 Months (Group A Only) post final treatment
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%)
Group
Value
95% CI
Group A: PicoPlus for Unwanted Tattoos.
0
Group B: PicoPlus for Other Dermatological Conditions
6
Group A: PicoPlus for Unwanted Tattoos.
3
Group B: PicoPlus for Other Dermatological Conditions
3
Group A: PicoPlus for Unwanted Tattoos.
3
Group B: PicoPlus for Other Dermatological Conditions
0
Group A: PicoPlus for Unwanted Tattoos.
0
Group B: PicoPlus for Other Dermatological Conditions
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected up to 6 months post final treatment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Group A: PicoPlus for Unwanted Tattoos.
Serious: 0/11 (0%)
Deaths: 0/11
Group B: PicoPlus for Other Dermatological Conditions
This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CynosureLutronic
Last refreshed: 20 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03415685.