Status:
COMPLETED
A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles
Lead Sponsor:
Candela Corporation
Conditions:
Wrinkle
Eligibility:
All Genders
18-75 years
Brief 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 sa...
Detailed 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 Mat...
Eligibility Criteria
Inclusion
- Met eligibility criteria under source study FUFT2002 and enrolled into FUFT2002 study (NCT # pending).
- Received full face treatment with 27W Matrix Pro applicator only.
- Have baseline and follow-up assessments obtained.
- Have photography obtained with the VISIA standardized camera system (Appendix III).
Exclusion
- Sun exposure during the course of the study.
- Aesthetic procedures and/or treatments during the course of the study.
- Any violation of study treatment instructions.
- Upon inspection, any differences in baseline and follow up photos that would not make evaluation of photos viable (e.g. chin placement, facial expression).
- Any protocol deviation or change in study visit activities that would jeopardize reliability or validity of the retrospective review
Key Trial Info
Start Date :
October 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06219278
Start Date
October 29 2023
End Date
July 1 2024
Last Update
October 8 2024
Active Locations (2)
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1
Candela Institue for Excellence
Marlborough, Massachusetts, United States, 01752
2
Syneron Medical
Yokneam Illit, Israel