Matrix Pro for Loose Skin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Candela Corporation

Must not be taking: Immunosuppressants, Corticosteroids, Anticoagulants, others

Disqualifiers: Pregnancy, Cancer, Cardiac disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12-18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Matrix Pro treatment for individuals with loose skin around the eyebrows, neck, and lower face. The study divides participants into two groups: one targets the upper face, including the eyebrows, and the other focuses on the lower face and neck. It suits individuals with noticeable skin sagging in these areas who are willing to try a new treatment involving radiofrequency microneedling (tiny needles combined with heat). Participants must adhere to study guidelines and refrain from other cosmetic procedures during the trial. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for skin rejuvenation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must avoid certain aesthetic procedures and treatments like neuromodulators and injectable fillers during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Matrix Pro treatment, which uses radiofrequency (RF) microneedling, is generally well-tolerated. Studies on eyebrow lifts and treatments for the chin and neck areas have demonstrated promising safety results. The FDA has approved the Matrix Pro device, confirming it meets specific safety standards for skin improvement.

These studies have found the treatment to be safe for a wide range of skin types, from light to dark. While any procedure can have side effects, data suggest that any negative effects are minor and temporary, such as redness or swelling that resolves quickly.

The trial under consideration tests the same technology, already studied in other settings, indicating a strong safety record for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for loose skin, such as surgical facelifts or laser therapy, Matrix Pro offers a non-invasive approach that targets specific facial zones with precision. One of its unique features is its ability to treat both the upper face, including the forehead and mid-cheek area, and the lower face, like the submentum and neck. Researchers are excited because Matrix Pro promises to deliver effective skin-tightening results without the downtime or risks associated with more invasive procedures. This innovative method could offer a faster, more convenient solution for those seeking to rejuvenate their appearance.

What evidence suggests that Matrix Pro might be an effective treatment for loose skin?

Research has shown that Matrix Pro, a device using radiofrequency (RF) technology, effectively treats loose skin. Studies have found noticeable improvements in wrinkles, with scores dropping from 3.00 to 2.71 after using the device. In this trial, participants will be assigned to different treatment zones. Zone 1 focuses on the upper face, including the eyebrows, while Zone 2 targets the lower face, including the neck. RF microneedling, a key part of Matrix Pro's technology, lifts and tightens loose skin, especially around the eyebrows and neck. This technology combines RF, microneedling, and infrared light to firm the skin and reduce wrinkles. Although the exact mechanism remains unclear, the results suggest that Matrix Pro could be a promising option for effectively treating loose skin. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-75 with loose skin around the eyebrows or neck, who are willing to avoid certain cosmetic procedures and maintain their weight during the study. Pregnant individuals, those with severe health conditions, abnormal scarring tendencies, recent aesthetic treatments in the target area, or allergies to specific medications cannot participate.

Inclusion Criteria

Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials

I have loose skin around my eyebrows, chin, or neck suitable for RF microneedling.

I will not use neuromodulators, fillers, or undergo skin treatments during the study.

Exclusion Criteria

Pregnant or planning to become pregnant, having given birth less than 3-months prior to enrollment into the study, and/or breast feeding

History of abnormal wound healing, keloid, or hypertrophic scar formation

I do not have severe heart problems or uncontrolled diabetes/thyroid issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive up to three treatments with the Matrix Pro Applicator for lifting the eyebrow and/or improving lax tissue in the submental and neck areas

12-18 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Matrix Pro

Trial Overview The Matrix Pro device is being tested for its safety and effectiveness in lifting eyebrow and submental/neck laxity. Participants will undergo RF microneedling treatment in a prospective, non-randomized study across multiple centers.

How Is the Trial Designed?

Group I: Zone 2: Submentum and Neck Experimental Treatment 1 Intervention

Treatment of the lower face including mid to low cheek, submentum, and neck

Group II: Zone 1: Eyebrow Lift Experimental Treatment 1 Intervention

Treatment of the upper face including treatment of forehead to mid cheek

Who Is Running the Clinical Trial?

Candela Corporation

Lead Sponsor

Trials

22

Recruited

2,200+

Published Research Related to This Trial

Patient-reported outcomes (PROs) are increasingly recognized as valuable measures of how new drug treatments affect patients, and their inclusion in drug development can influence approval and labeling processes.

A study found that PRO data were included in 30% of new drug labels, particularly in areas like anti-inflammatory and respiratory treatments, highlighting the importance of these outcomes in communicating treatment effectiveness to stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the value of treatment to patients: patient-reported outcomes in drug development. Willke, RJ.[2021]

Collagen injection therapy for stress urinary incontinence in elderly women showed that 48.3% of patients were totally dry and 31.0% were socially continent after an average follow-up of 24.4 months, indicating moderate efficacy.

Approximately 41.3% of patients who initially achieved continence experienced recurrent leakage, and only 42.1% of those who were reinjected regained continence, highlighting the need for patients to be informed about the potential for recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagen injection therapy in elderly women: long-term results and patient satisfaction. Winters, JC., Chiverton, A., Scarpero, HM., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-cutis-laxa-8-2024-d9c1e

Matrix Pro for Loose Skin · Info for Participants Trial Overview The Matrix Pro device is being tested for its safety and effectiveness in lifting eyebrow and submental/neck laxity. Participants will undergo RF ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06640998

Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift ... Presence of laxity to the eyebrow and/or submentum and neck appropriate for RF microneedling treatment. Willing to receive Matrix treatments with The Matrix Pro ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12243918/

Clinical application of radiofrequency technology in the ... One week after the third treatment, the mean facial wrinkle severity score had significantly decreased from 3.00 ± 0.79 to 2.71 ± 0.47 (t = 2.58, P < 0.05).

4. candelamedical.com candelamedical.com/products/matrix/

Matrix™ RF Microneedling Device Discover a multi-technology skin renewal system combining RF, microneedling, and infrared light to treat volume loss, skin laxity, fine lines, and wrinkles.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4631236/

Radiofrequency for the treatment of skin laxity: mith or truth The analyzed studies suggest that radiofrequency is effective, however the physiological mechanisms and the required parameters are not clear in the literature.

6. realself.com realself.com/nonsurgical/matrix-pro

Matrix Pro Treatment Benefits, Safety, Results Matrix Pro by Candela is an FDA-cleared radiofrequency (RF) microneedling skin rejuvenation treatment. Part of the new Matrix system.

7. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/efficacy-and-safety-of-matrix-pro/

Efficacy and Safety of Matrix Pro 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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10929553/

Development of Home Beauty Devices for Facial ... This study aims to verify the safety and effectiveness of these home beauty devices in treating skin aging based on relevant efficacy evaluation indicators.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.15672

The efficacy and safety of the high‐intensity parallel beam ... Our study demonstrates that the novel high-intensity parallel beam US device is clinically safe and effective for skin tightening in the lower face area.