By InvitationNot Applicable

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

United States150 participantsStarted 2024-09-09

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
✓. 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 applicator.
✓. Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.
✓. Willingness to provide signed, informed consent to participate in the study.
✓. 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.
✓. Willing to abstain from other aesthetic procedures which may change or modify the eyelashes and/or eyebrows throughout the entire study duration.
✓. Willing to maintain stable weight and avoid fluctuations of +/- 8lbs throughout the entire study duration.

✕. Pregnant or planning to become pregnant, having given birth less than 3-months prior to enrollment into the study, and/or breast feeding.
✕. Pacemaker, internal defibrillator, or any active electrical implant anywhere in the body.
✕. 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.
✕. Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.
✕. Weight has fluctuated +/- 8lbs within the past year.
✕. Skin cancer in the treatment area or history of melanoma.
✕. History of or current cancer and/or subject has undergone chemotherapy within the last 12 months.
✕. Severe concurrent conditions, such as uncontrolled cardiac disorders, or poorly controlled endocrine disorders (diabetes or Hyper/Hypothyroidism).

Improvements in lifting of lax tissue

Timeframe: 3 months post last treatment

NCT IDNCT06640998

SponsorCandela Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
✓. 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 applicator.
✓. Able and willing to comply with the treatment/follow-up schedule and with all study (protocol) requirements.
✓. Willingness to provide signed, informed consent to participate in the study.
✓. 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.
✓. Willing to abstain from other aesthetic procedures which may change or modify the eyelashes and/or eyebrows throughout the entire study duration.
✓. Willing to maintain stable weight and avoid fluctuations of +/- 8lbs throughout the entire study duration.

✕. Pregnant or planning to become pregnant, having given birth less than 3-months prior to enrollment into the study, and/or breast feeding.
✕. Pacemaker, internal defibrillator, or any active electrical implant anywhere in the body.
✕. 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.
✕. Severe eyebrow heaviness/Laxity and/or severe submental fullness/ laxity of neck skin.
✕. Weight has fluctuated +/- 8lbs within the past year.
✕. Skin cancer in the treatment area or history of melanoma.
✕. History of or current cancer and/or subject has undergone chemotherapy within the last 12 months.
✕. Severe concurrent conditions, such as uncontrolled cardiac disorders, or poorly controlled endocrine disorders (diabetes or Hyper/Hypothyroidism).