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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, non-randomized, multi-center, pivotal clinical trial

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.

What data supports the effectiveness of the treatment Matrix Pro for loose skin?

The research on patient-reported outcomes (PROs) highlights their importance in evaluating how treatments impact patients' satisfaction and quality of life, which can be relevant for treatments like Matrix Pro. Additionally, studies on collagen injection therapy, which may share similarities with Matrix Pro, show long-term patient satisfaction, suggesting potential effectiveness in improving skin appearance. ^{1 2 3 4 5}

How does the treatment Matrix Pro for loose skin differ from other treatments?

Matrix Pro is unique because it uses a particulate acellular human dermal matrix that can be injected at higher concentrations than other products, potentially reducing the need for repeated treatments. This matrix is processed to minimize damage, allowing it to last longer and promote better integration with the body's own cells, which can enhance skin remodeling. ^{6 7 8 9 10}

Eligibility Criteria

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

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

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

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

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Patient-reported outcomes: advances in research and practical application]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Body-QoL(®): patient reported outcomes in body contouring surgery patients [corrected]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Collagen injection therapy in elderly women: long-term results and patient satisfaction. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Development and Validation of the Eyelash Satisfaction Questionnaire. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Particulate dermal matrix as an injectable soft tissue replacement material. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Matrixyl Patch vs Matrixyl Cream: A Comparative In Vivo Investigation of Matrixyl (MTI) Effect on Wound Healing. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Skin irritation and sensitization of swine acellular dermal matrix treated with hyaluronic acid]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Neck contracture release with matriderm collagen/elastin dermal matrix. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A novel multiparameter in vitro model of three-dimensional cell ingress into scaffolds for dermal reconstruction to predict in vivo outcome. [2021]