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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06219278
Other study ID # MXP23001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 29, 2023
Est. completion date May 2024

Study information

Verified date March 2024
Source Candela Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a retrospective chart review of data from the multi-site prospective clinical trial, "Functional Usability and Feasibility Testing of the Profound Matrix™ System (FUFT2002)" to evaluate the safety and efficacy of the Profound Matrix System Matrix Pro applicator for the treatment of wrinkles.


Description:

This was a retrospective medical record review of subject data from the source study FUFT2002 to evaluate the safety, efficacy, tolerability, and usability of the Profound MatrixTM System with the Matrix Pro Applicator for the treatment of wrinkles.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date May 2024
Est. primary completion date December 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Met eligibility criteria under source study FUFT2002 and enrolled into FUFT2002 study (NCT # pending). 2. Received full face treatment with 27W Matrix Pro applicator only. 3. Have baseline and follow-up assessments obtained. 4. Have photography obtained with the VISIA standardized camera system (Appendix III). Exclusion Criteria: 1. Sun exposure during the course of the study. 2. Aesthetic procedures and/or treatments during the course of the study. 3. Any violation of study treatment instructions. 4. Upon inspection, any differences in baseline and follow up photos that would not make evaluation of photos viable (e.g. chin placement, facial expression). 5. Any protocol deviation or change in study visit activities that would jeopardize reliability or validity of the retrospective review

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Profound Matrix
The source study consisted of up to three treatment visits with treatment intervals 6 weeks ± 2 weeks

Locations

Country Name City State
Israel Syneron Medical Yoqne'am 'Illit
United States Candela Institue for Excellence Marlborough Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Candela Corporation

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in facial wrinkles Improvement in the appearance of wrinkles was assessed by three (3) blinded evaluators comparing photographs taken at Baseline/Pre-treatment and at the 3-month follow-up (post final treatment) Approximately 6 months following baseline assessment
Secondary Subject Global Aesthetic Improvement Scale (GAIS) Assessment of Subject Assessment of Improvement via GAIS ratings at the study endpoint (3MFU) using a 5-point scale (-1= worse to 3= very much improved) Approximately 6 months following baseline assessment
Secondary Subject Global Aesthetic Improvement Scale (GAIS) Assessment of Subject Assessment of Improvement via GAIS ratings at follow up timepoint using a 5-point scale (-1= worse to 3= very much improved) Approximately 4 months following baseline assessment
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