Adults 18 to 65, any sex, with Scarring or Acne. 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.
Acne Scarring ImprovementPrimary· Baseline, and at 12 weeks post final treatment (up to 30 weeks)
An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment
Baseline Acne Scar Assessment Scale Score
Group
Value
95% CI
Enlighten™ Laser and a MLA Attachment
4
± 0
12 weeks post final treatment Acne Scar Assessment Scale Score
Group
Value
95% CI
Enlighten™ Laser and a MLA Attachment
4
± 0
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 weeks post-final treatment, up to 8 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cutera Inc.
Last refreshed: 26 September 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/NCT03430921.