Efficacy and Safety of Matrix Pro
Research type
Research Study
Full title
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment for Facial, Submental and Neck Laxity
IRAS ID
330964
Contact name
Firas Al-Niaimi
Contact email
Sponsor organisation
Candela Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The PFX22003 clinical study is to evaluate the efficacy and safety looking into treatment with the Matrix Pro Applicator on the Profound Matrix delivery system for the improvement of facial and/or submental and neck laxity. Candela Corporation has developed its next generation radiofrequency (RF) system composed of: Profound Matrix System with Matrix Pro, Sublative RF and Sublime applicators. Sublime and Sublative RF applicators are FDA cleared and CE marked. The Matrix-Pro Applicator is not yet CE marked and is investigational in this study. The Matrix Pro applicator is a short pulse radiofrequency (RF) micro-needling device, utilizing novel and state-of-the art technology to provide users with a customisable treatment approach based on patient needs and used for the indication of treatment of facial and /or submental, and neck laxity. This study is open label. Each treatment is 6 weeks +/- 2 weeks apart and then continued with two Follow-up visits: 1-month (4wks ± 2 wks) and 3-month (13 wks +/- 2 wks) after the last treatment. If required, additional follow-up visits may be performed per Sponsor and PI discretion. All participants will be evaluated for global improvement, improvement in facial laxity, treatment satisfaction, pain/discomfort during the treatments, and severity of local skin responses and unexpected adverse events in post-treatments using applicable scales/measures corresponding to each endpoint. A sample size of 60 study subjects has been determined to provide appropriate sample population for statistical analysis and generalizability of results. All data will be captured on paper CRFs and will be filed in subject study binders.
REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0129
Date of REC Opinion
21 Nov 2024
REC opinion
Further Information Favourable Opinion