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NCT03430921

Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment

Completed NA Results posted Last updated 26 September 2023
What this trial tests

NA trial testing Enlighten™ Laser and a MLA Attachment in Scarring in 4 participants. Completed in 30 May 2018.

Timeline
15 August 2017
Primary endpoint
30 May 2018
30 May 2018

Quick facts

Lead sponsorCutera Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment4
Start date15 August 2017
Primary completion30 May 2018
Estimated completion30 May 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cutera Inc.

Who can join

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 Improvement Primary · 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
GroupValue95% CI
Enlighten™ Laser and a MLA Attachment4± 0
12 weeks post final treatment Acne Scar Assessment Scale Score
GroupValue95% CI
Enlighten™ Laser and a MLA Attachment4± 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.

Enlighten™ Laser and a MLA Attachment
Serious: 0/4 (0%)
Deaths: 0/4
Other adverse events (3 terms — click to expand)

ReactionSystemEnlighten™ Laser and a MLA…
ErythemaSkin and subcutaneous tissue disorders
EdemaSkin and subcutaneous tissue disorders
DiscomfortSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT03430921 adverse events section.

Sponsor's own description

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.

Verify or expand the search:

Other recruiting trials for Scarring

Currently open trials in the same condition.

Other Cutera Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing