Can a dissolving thread smooth away wrinkles?
NCT ID NCT06404372
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial tests a new type of dissolvable thread, called the Demetech Barbed PDO Suture, to see if it can safely reduce wrinkles in the midface (cheek area). About 57 adults with mild to moderate wrinkles will receive the thread, which is designed to lift and smooth the skin over time. Researchers will check how much wrinkles improve at 3 and 6 months, and track any side effects over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Demetech Barbed PDO Suture, an absorbable thread used to lift and smooth midface wrinkles
- What this could lead to
- If successful, this could offer a non-surgical, temporary option for reducing midface wrinkles with minimal downtime.
- What could go wrong
- This is a small, early-stage study (57 people) and results may not apply to everyone. Risks include possible side effects like pain, swelling, or thread migration, and the effect is temporary.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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57 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Jul 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female subjects, 22+ years of age. 2. Subject received a rating, in each cheek, by PI of at least Class 1 or more for wrinkling in the midface according to the Lemperle Scale Classification of Facial Wrinkling. 3. If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must have a confirmed negative urine pregnancy test result at screening. If treatment is not provided at the screening visit, a negative urine pregnancy test result is required within 7 days before treatment. 4. If a woman of childbearing potential, subject confirms she will utilize at least one form of contraception throughout the duration of the study. 5. Subjects who desire cheek lifting to correct age-related wrinkles in the midface as recommended by the treating investigator. 6. Subjects who are able to understand the study requirements, including the obligation not to receive any other facial procedures or treatments affecting mid-face at any time during the study. 7. Subjects who are willing to participate in the study and to sign a witnessed/informed consent form. 8. Subjects who are logistically able to present for all study visits and meet all study requirements. 9. Subjects who are willing to complete the 30-day diary. 10. Subjects who pass the pinprick and/or cotton swab facial nerve assessment. Exclusion Criteria: 1. Abnormal rating in midface sensation, with inability to feel a 0.4 G monofilament or a cotton wisp at any site on the midface. 2. Active acne or prominent acne scars in the treatment area. 3. Active inflammatory or infectious conditions. 4. Allergy or foreign body sensitivities to plastic biomaterials. 5. Known bleeding disorder. 6. Breastfeeding, pregnant, or not on/willing to use contraception if of childbearing potential. 7. Collagen skin disorder. 8. Pre-existing facial asymmetry. 9. History of any device use on the mid-face in the prior 6 months (e.g., laser, IPL, radiofrequency, ultrasound, micro-needling, micro needle radiofrequency, or cool based treatments). 10. History of autoimmune or connective tissue disease. 11. History of facelift, midface lift, lower facelift, or neck lift that changes the facial structure and anchor points. 12. History of fat transfer to the midface. 13. History of injectable fillers other than temporary fillers such as Hyaluronic Acid (HA) or Radiesse to the midface at any time. Permanent and semi-permanent fillers are not allowed (e.g., Poly-L-lactic acid (PLLA), Sculptra). 14. History of Kybella in the prior 6 months. 15. History of facial trauma in the mid-face. 16. History of facial surgical procedures. 17. Inability to chew, puff cheek, or smile broadly. 18. Metabolism irregularities. 19. On immunosuppressive therapy. 20. Recent weight loss or intention to lose a significant amount of weight during the study period (2 BMI Points). 21. Subjects who have undergone cosmetic facial plastic surgery (with the exception of rhinoplasty or upper blepharoplasty, more than 2 years prior to enrollment), tissue grafting, or tissue lifting or augmentation with any permanent or semi-permanent filler. 22. Subjects who have had temporary facial dermal filler injections below the orbital rim with HA-based fillers or Radiesse 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 who were planning to undergo any of these procedures at any time during the study. 23. Subjects who have very thin skin in the mid-face region, who have the tendency to accumulate fluid in the lower eyelids, or who have large infraorbital fat pads. 24. Subjects who have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy, partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease. 25. Subjects who have serious concurrent illness which may lead to problems with wound healing (e.g., uncontrolled diabetes or vascular disease). 26. Subjects with known or suspected family history of problems with keloid scarring. 27. Subjects with serious neurological or psychological conditions which could prevent the subject from cooperating with treatment or post-procedure care and assessment. 28. Smokers, since this may compromise wound healing. 29. Subjects who have a current or prior history within the last 3 years of neoplasm and/or any active neoplasm in the face or that in the opinion of the Investigator may make them not a suitable candidate. 30. Subjects currently enrolled in other clinical trials. 31. Subjects taking Warfarin or other anticoagulants. These subjects may experience a significant risk of problems with post-operative bleeding. 32. Subjects who have taken, in the last 2 weeks, ad-lib medication or herbal supplements that may increase risk of bleeding. This includes aspirin or other herbal supplements known to increase risk of bleeding. 33. Subjects with significant co-morbidities (e.g., heart disease, strokes, or angina) that in the opinion of the Investigator may prevent the subject from completing the study. 34. Subjects with planned cosmetic procedures, facial or dental surgery during the follow-up period. 35. Other concerning health issue in the opinion of the Investigator.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cosmetic Injectables Center
Sherman Oaks, California, 91423, United States
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Dr. Kristin Tarbet Facial Plastic Surgery
Bellevue, Washington, 98004, United States
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Rejuva Medical Aesthetics
Los Angeles, California, 90025, United States
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Vedas Med Spa
The Woodlands, Texas, 77381, United States
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