Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity

NCT ID: NCT06640998

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2028-09-30

Brief Summary

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

Detailed Description

This is a two-arm study. Eligible participants will 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. Treatments will be spaced approximately 6 weeks apart (± 2 weeks), and all participants will undergo follow-up evaluations at 1 month (± 2 weeks) and 3 months (± 2 weeks) after the final treatment.

Each investigational site will treat two areas: In arm 1, the upper face, including the forehead and peri-orbital area, to lift the eyebrows. In arm 2, the lower face, including the submental and neck areas, to lift lax tissue. Each patient could be assigned to both arms. Treatment may occur immediately after the screening and enrollment visit or at a later date, depending on site scheduling. Additional follow-up visits may be required at the investigator's discretion.

Conditions

Laxity; Skin

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zone 1: Eyebrow Lift

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

Group Type: EXPERIMENTAL

Matrix Pro

Intervention Type: DEVICE

Study subjects received up to three (3) study treatments with the Matrix Pro applicator

Zone 2: Submentum and Neck

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

Group Type: EXPERIMENTAL

Matrix Pro

Intervention Type: DEVICE

Study subjects received up to three (3) study treatments with the Matrix Pro applicator

Interventions

Matrix Pro

Study subjects received up to three (3) study treatments with the Matrix Pro applicator

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.

2. Presence of laxity to the eyebrow and/or submentum and neck appropriate for RF microneedling treatment.

3. Willing to receive Matrix treatments with The Matrix Pro applicator.

4. Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.

5. Willingness to provide signed, informed consent to participate in the study.

6. Willing to abstain from neuromodulators, injectable fillers and any aesthetic procedure which may resurface the skin and/or modify the dermal tissue throughout the entire study duration.

7. Willing to abstain from other aesthetic procedures which may change or modify the eyelashes and/or eyebrows throughout the entire study duration.

8. Willing to maintain stable weight and avoid fluctuations of +/- 8lbs throughout the entire study duration.

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

Exclusion Criteria

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

2. Pacemaker, internal defibrillator, or any active electrical implant anywhere in the body.

3. Superficial metal or other implants in the treatment area, unless these implants can be removed or covered with rolled gauze during treatment, except superficial dental implants.

4. Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.

5. Weight has fluctuated +/- 8lbs within the past year.

6. Skin cancer in the treatment area or history of melanoma.

7. History of or current cancer and/or subject has undergone chemotherapy within the last 12 months.

8. Severe concurrent conditions, such as uncontrolled cardiac disorders, or poorly controlled endocrine disorders (diabetes or Hyper/Hypothyroidism).

9. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.

10. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following initiation of a prophylactic regimen.

11. Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and/or severe active inflammatory acne.

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

13. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders.

14. Known allergy to medication to be used during treatments such as lidocaine, benzocaine, tetracaine, Xylocaine, or Pro-Nox™ (a 50% oxygen and 50% nitrous oxide mixture (laughing gas).

15. On systemic corticosteroid therapy in past six months.

16. Currently taking anticoagulants.

17. Tattoos in the intended treatment area

18. Excessively tanned skin.

19. Is unwilling to have hair shaved from the treatment area, if applicable.

20. Facelift and/or neck lift in the last 12 months.

21. Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area.

22. Neuromodulator injections (e.g. Botox®), collagen, non-permanent soft-tissue and/or dermal filler, and/or fat injections or other methods of augmentation with injected biomaterial in the treated area within the last 6-months.

23. Permanent synthetic fillers (e.g. silicone) or non-absorbable threads in the treatment area.

24. Absorbable facial threads within the last 2 years.

25. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Candela Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Candela Institute for Excellence

Marlborough, Massachusetts, United States

Countries

United States

Other Identifiers

MXP24001

Identifier Type: -

Identifier Source: org_study_id