PDO THREADLIFT CLINICAL STUDY

Mid-face wrinkles are often the result of the natural aging process and involve sagging of the facial structures and loss of subcutaneous fat. A number of treatment options are available including surgical procedures, fat transfer, and injection of various dermal fillers. Each of these options having varying levels of effectiveness and durability and, as with any medical procedure have safety risks. Barbed polydioxanone (PDO) sutures are absorbable threads with barbed sutures along the surface indicated for the treatment of mid-face wrinkles.

PDO sutures have long been used for tissue approximation and have been shown to be safe to use. However, there have been no sutures approved in the US for mid-face wrinkle reduction indication. Therefore, we wish to conduct this prospective study in order to observe safety and effectiveness of PDO suture use in reducing mid-face wrinkles.    

 

CLINICAL STUDY

Rejuva Medical Aesthetics is recruiting participants for a clinical research study to evaluate the safety and effectiveness of barbed PDO sutures for the temporary treatment of mid-face wrinkles.

Purpose of the Study:

The purpose of this study is to evaluate the safety and effectiveness polydioxanone (PDO) dissolvable threads for the temporary treatment of mid-face wrinkles.

Who may participate in this study?

You may qualify for this research study if the following applies to you:

  • You are at least 22 years of age 

  • You are not currently pregnant or breastfeeding, and willing to use one form of contraception throughout the duration of the study

  • If you are of childbearing potential and have not been surgically sterilized, you are willing to undergo pregnancy test within seven (7) days before treatment, and you will commit to utilizing one form of contraception throughout the duration of the study

  • You do not have a history of any device use on the face in the prior 6 months (laser, IPL, radio-frequency, ultrasound, micro needling, micro needle RF, or cool-based treatments)

  • You are willing to not receive any other facial procedures or treatments affecting mid-face at any time during the study. These include procedures or treatments done at home or with a professional. Facial treatments include lasers, facial massages, and anything beyond common skincare routine.

  • You do not have active acne or prominent acne scars

  • You do not have active inflammatory or infectious conditions

  • You do not have a known bleeding disorder

  • You do not have allergy or foreign body sensitivities to plastic biomaterials

  • You do not have a collagen skin disorder

  • You do not have pre-existing facial asymmetry

  • You do not have a history of autoimmune or connective tissue disease

  • You do not have a history of facial trauma 

  • You do not have an inability to chew, puff cheek, or smile broadly

  • You do not have metabolism irregularities

  • You are not on immunosuppressive therapy

  • You have not recently lost weight or intend to lose a significant amount of weight during the study period (2 BMI Points)

  • You do not smoke

  • You do not have a current or prior history within the last 3 years of neoplasm and/or any active neoplasm

  • You are not participating in any other clinical trial

  • You are not taking Warfarin or other anticoagulants

  • You do not have a history of facial surgical procedures

  • You do not have any planned cosmetic procedures, facial or dental surgery

  • You do not have a history of facelift, mid-face lift, lower facelift or necklift 

  • You do not have a history of fat transfer to the mid-face

  • You do not have a history of injectable fillers other than HA to the midface at any time

  • You do not have a history of Kybella in the prior 6 months

  • You have not undergone cosmetic facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue lifting or augmentation with any permanent or semi-permanent filler

  • You have not had temporary facial dermal filler injections with HA-based fillers within 18 months, porcine-based collagen fillers within 24 months, or neuromodulator injections to the midface or lateral canthal lines, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months of entry in the study or is  planning to undergo any of these procedures at any time during the study

  • You must be logistically able to be present for all study visits and meet all study requirements

  • You are willing to complete the required 30-day diary

  • You must agree to the publication and use of photos/videos documenting baseline, treatment progress and end of study outcomes

There are other eligibility requirements. A final decision on whether this clinical trial is suitable for you will be made after you speak with the study doctor at the research site.

Your next steps

  • See if the study may be suitable for you by reviewing the criteria above

  • Submit your contact details to study personnel

  • Be contacted by a study coordinator for further information