CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Investigational Enlighten Devicedevice
Likely dose
Investigational Enlighten device — up to 3 laser treatments, spaced 4–6 weeks apartAI-extracted
Key inclusion· 7
  • ✓Age 18–65 years
  • ✓Fitzpatrick skin type I–III
  • ✓Clinical diagnosis of benign pigmented lesions on hand, body, or face
  • ✓At least 5 benign pigmented lesions in treatment area, 2–8 mm diameter
Key exclusion· 20
  • ✕Participation in another clinical trial within 6 months prior to or during the study
  • ✕Prior cosmetic treatment (chemical peel, laser, light-based procedure, or surgery) to target area within 6 months
  • ✕Pre-malignant or malignant lesion in treatment area or history thereof (including pigmented actinic keratosis, lentigo maligna, lentigo maligna melanoma)
  • ✕Signs of actinic bronzing or excessive tanning in areas to be treated, and unable or unlikely to refrain from tanning

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02635880
NCT02635880N/ACompleted
CompareCT.gov

A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal

Cutera Inc.·interventional·Posted Dec 21, 2015·Updated Jul 6, 2018

In Brief

A clinical study evaluating Investigational Enlighten Device for Pigmented Skin Lesion of Suspected Benign Nature. Completed, enrolled 32 participants across 1 site.

Detailed Summary

To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for removal of benign pigmented lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPigmented Skin Lesion of Suspected Benign Nature
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 21, 2015
Enrollment StartSep 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionMar 23, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.5 years ago

Interventions

Investigational Enlighten Devicedevice

Up to 3 laser treatments, spaced 4 to 6 weeks apart