Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 6:28 PM
Study NCT ID:
NCT03284333
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2017-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars
Sponsor:
Cutera Inc.
Organization:
Study Overview
Official Title:
Open-label, Prospective, Multicenter Study to Evaluate the Cutera enLighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate and Severe Acne Scars
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne scars.
Detailed Description:
This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars. Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will return to the site after all study treatments have been delivered for two follow-up visits: 6 and 12 weeks (± 2 weeks) following their final study treatment.
1. The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the patients and an improvement of one point in the ASAS.
2. The Secondary Efficacy Endpoints as the:
* Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatment as assessed by the investigator starting from the 2nd treatment onward, and
* Subject satisfaction levels as assessed from the subject questionnaire completed at the final follow-up visit 12 weeks post final treatment.
3. The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array handpiece attachment as assessed by the frequency and severity of device related adverse events,
4. The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens Array handpiece attachment for the improvement of skin quality as assessed by the investigator and/or blinded evaluators 12-weeks-post final study treatment.
1. The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the patients and an improvement of one point in the ASAS.
2. The Secondary Efficacy Endpoints as the:
* Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatment as assessed by the investigator starting from the 2nd treatment onward, and
* Subject satisfaction levels as assessed from the subject questionnaire completed at the final follow-up visit 12 weeks post final treatment.
3. The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array handpiece attachment as assessed by the frequency and severity of device related adverse events,
4. The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens Array handpiece attachment for the improvement of skin quality as assessed by the investigator and/or blinded evaluators 12-weeks-post final study treatment.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: