WrinkleNCT06404372
To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture
A study testing Demetech Barbed PDO Suture in people with Wrinkle, run by Sutura Medical Technology LLC at 4 sites in United States.
Trial summary
The clinical trial, sponsored by Sutura Medical Technology, Inc., is a pivotal, blinded, multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture, an absorbable Polydioxanone suture, for the temporary treatment of midface wrinkles. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Demetech Barbed PDO Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Jul 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects, 22+ years of age.
- 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.
- 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.
- If a woman of childbearing potential, subject confirms she will utilize at least one form of contraception throughout the duration of the study.
- Subjects who desire cheek lifting to correct age-related wrinkles in the midface as recommended by the treating investigator.
- 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.
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- Subjects who are willing to participate in the study and to sign a witnessed/informed consent form.
- Subjects who are logistically able to present for all study visits and meet all study requirements.
- Subjects who are willing to complete the 30-day diary.
- Subjects who pass the pinprick and/or cotton swab facial nerve assessment.
Who cannot join
- Abnormal rating in midface sensation, with inability to feel a 0.4 G monofilament or a cotton wisp at any site on the midface.
- Active acne or prominent acne scars in the treatment area.
- Active inflammatory or infectious conditions.
- Allergy or foreign body sensitivities to plastic biomaterials.
- Known bleeding disorder.
- Breastfeeding, pregnant, or not on/willing to use contraception if of childbearing potential.
Show all 35Show fewer
- Collagen skin disorder.
- Pre-existing facial asymmetry.
- 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).
- History of autoimmune or connective tissue disease.
- History of facelift, midface lift, lower facelift, or neck lift that changes the facial structure and anchor points.
- History of fat transfer to the midface.
- 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).
- History of Kybella in the prior 6 months.
- History of facial trauma in the mid-face.
- History of facial surgical procedures.
- Inability to chew, puff cheek, or smile broadly.
- Metabolism irregularities.
- On immunosuppressive therapy.
- Recent weight loss or intention to lose a significant amount of weight during the study period (2 BMI Points).
- 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.
- 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.
- 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.
- 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.
- Subjects who have serious concurrent illness which may lead to problems with wound healing (e.g., uncontrolled diabetes or vascular disease).
- Subjects with known or suspected family history of problems with keloid scarring.
- Subjects with serious neurological or psychological conditions which could prevent the subject from cooperating with treatment or post-procedure care and assessment.
- Smokers, since this may compromise wound healing.
- 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.
- Subjects currently enrolled in other clinical trials.
- Subjects taking Warfarin or other anticoagulants. These subjects may experience a significant risk of problems with post-operative bleeding.
- 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.
- 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.
- Subjects with planned cosmetic procedures, facial or dental surgery during the follow-up period.
- Other concerning health issue in the opinion of the Investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dr. Kristin Tarbet Facial Plastic Surgery
Bellevue, Washington, 98004
Rejuva Medical Aesthetics
Los Angeles, California, 90025
Cosmetic Injectables Center
Sherman Oaks, California, 91423
Vedas Med Spa
The Woodlands, Texas, 77381
About this study
Official title: A Pivotal, Blinded Multi-Center Study to Show the Safety and Effectiveness of the Demetech Barbed PDO Suture
The clinical trial, sponsored by Sutura Medical Technology, Inc., is a pivotal, blinded, multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture, an absorbable Polydioxanone suture, for the temporary treatment of midface wrinkles. The trial will enroll 57 subjects across up to four sites, following them over a 12-month period to evaluate improvements in wrinkles based on the Lemperle Classification Facial Wrinkle Scale. Primary endpoints include assessing the rate of adverse events and a significant reduction in wrinkle severity at 6 months, with secondary endpoints focusing on longer-term results and patient satisfaction.
Read the detailed description
The study will be a pivotal, blinded, multi-center study to evaluate the safety and effectiveness of Demetech Barbed PDO Suture for the treatment of mid face wrinkles. Subjects who meet Inclusion/Exclusion criteria will receive treatment with Demetech Barbed PDO Sutures. Fifty-seven subjects will be treated. In addition, up to 2 run-in subjects may be treated with Demetech Barbed PDO Sutures by the investigator to allow the investigator to become familiar with Demetech Barbed PDO Suture characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort.
Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 12 months after treatment. Subjects will be followed up for safety via telephone or email at 72 hours after receiving treatment.
The primary effectiveness endpoint will be determined by the proportion of subjects with ≥1 point improvement on the Lemperle Classification of Facial Wrinkles Scale at 6 months compared to baseline as rated by a panel of three blinded evaluators. The Lemperle Scale will be used for photographic assessment by the blinded panel. Assessment of the secondary effectiveness endpoints will include the use of the Lemperle Scale by photograph by the blinded panel and live by the Investigator, as well as Investigator- and Subject-rated GAIS, and FACE-Q.
Safety will be assessed at each follow-up visit. Subjects will be seen for follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months from treatment.
- Conditions
- Wrinkle
- Being tested
- Demetech Barbed PDO Suture
- Keywords
- Suture, Sutura, Demetech Barbed PDO Suture, Novathreads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demetech Barbed PDO SutureDevice
The Demetech Barbed PDO Suture will be used for the correction of midface wrinkles in all patients enrolled in this study.
| Study group | Role | What they receive |
|---|---|---|
| Demetech Barbed PDO Suture | Experimental | Subjects who meet Inclusion/Exclusion criteria will receive treatment with Demetech Barbed PDO Sutures. Fifty-seven subjects will be treated. In addition, up to 2 run-in subjects may be treated with Demetech Barbed PDO Sutures by the investigator to allow the investigator to become familiar with Demetech Barbed PDO Suture characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort. Receives: Device: Demetech Barbed PDO Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement From Baseline on the Lemperle Classification Wrinkle Scale
The primary effectiveness endpoint is the percentage of subjects with ≥1 point improvement on the Lemperle Classification Facial Wrinkle Scale at 6 months compared to baseline, as rated by a panel of three blinded evaluators. The median score as rated by the blinded panel using subject photographs will be used to determine if a subject is a responder. Clinical effectiveness will be demonstrated by superiority of this 6-month response rate over a target rate of 60%
Measured: 6 Month
Secondary outcomes (8)
Percentage of Subjects With ≥1 Point Change From Baseline on the Lemperle Classification Facial Wrinkle Scale
Individual endpoint at 3 months for the percentage of subjects with ≥1 point change from baseline on the Lemperle Scale, as rated by a panel of three blinded evaluators. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.
Measured: 3, 9, and 12 Months
Change From Baseline on the Lemperle Classification Facial Wrinkle Scale as Rated by a Panel of Three Blinded Evaluators
Change from baseline at each timepoint of 3 and 6 months on the Lemperle Scale, as rated by a panel of three blinded evaluators. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.
Measured: 3 and 6 Month
Percentage of Subjects With ≥1 Point Change From Baseline on the Lemperle Classification Facial Wrinkle Scale
Individual endpoints at each timepoint of 3, 6, 9, and 12 months for the percentage of subjects with ≥1 point change from baseline on the Lemperle Scale, as rated by the Investigator. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.
Measured: 3, 6, 9, and 12 Months
Change From Baseline on the Lemperle Classification Facial Wrinkle Scale as Rated by the Investigator
Change from baseline at each timepoint of 3, 6, 9, and 12 months on the Lemperle Scale, as rated by the Investigator. The Lemperle Scale is a 6-point wrinkle classification scale with classification values of 0 to 5 wherein the higher value indicates more severe wrinkles, which are considered worse outcomes.
Measured: 3, 6, 9, and 12 Months
Responders on Investigator-rated Global Aesthetic Improvement Scale (GAIS)
Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for responders on Investigator-rated GAIS. GAIS (Global Aesthetic Improvement Scale) is a 7-point scale with values of -3 to 3 wherein the higher value indicates a greater degree of change in aesthetic appearance. Subjects must be at least Improved on both sides of the face to be considered a responder.
Measured: 6 Weeks, 3, 6, 9, 12 Months
Responders on Subject-rated Global Aesthetic Improvement Scale (GAIS)
Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for responders on Subject-rated GAIS. GAIS (Global Aesthetic Improvement Scale) is a 7-point scale with values of -3 to 3 wherein the higher value indicates a greater degree of change in aesthetic appearance. Subjects must be at least Improved on both sides of the face to be considered a responder.
Measured: 6 Weeks, 3, 6, 9, 12 Months
FACE-Q Age Appraisal as Rated by the Subject.
Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for change from baseline on the validated FACE-Q Age Appraisal scales as rated by the Subject. The FACE-Q Age Appraisal Scale is a patient-reported outcome measure that asks patients to select how many years older or younger they think they look compared with their actual age, ranging from -15 years to +15 years in increments of 1, with 0 being 'I look my age' at the center. The subject is instructed to circle only one number, and that number is used in analysis with no further derivation required. Treatment results at each individual timepoint are compared against baseline using a paired t-test.
Presumably as subjects would prefer to appear younger than their age, negative values are considered a better result; a mean change from baseline less than zero is considered a favorable response.
Measured: 6 Weeks, 3, 6, 9, 12 Months
FACE-Q Satisfaction With Cheeks
Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for change from baseline on the validated FACE-Q Satisfaction with Cheeks (FACE-Q Total Score) as rated by the Subject. The FACE-Q Satisfaction with Cheeks is a patient reported outcome which consists of 5 questions pertaining to different aspects of cheek appearance. Each is evaluated on a scale of 1 to 4, with 1 being Very Dissatisfied and 4 being Very Satisfied. The raw scores for items that make up a scale are added to provide a total score. The total score is converted to a RASCH-transformed score from 0 to 100. A higher total score is indicative of greater satisfaction with the appearance of their cheeks. Treatment results at each individual timepoint are compared against baseline using a paired t-test.
Measured: 6 weeks, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start18 Jul 2022
- Primary completion4 Dec 2023
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sutura Medical Technology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherly Soleiman, MD, Principal investigator, Cosmetic Injectables CenterChaitali Nangrani, MD, Principal investigator, Vedas Med SpaKristin Tarbet, MD, Principal investigator, Dr. Kristin Tarbet Facial Plastic SurgeryAmit Kocher, MD, Principal investigator, Rejuva Medical Aesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404372
- Sponsor's protocol ID
- CF-CLT-PRT
- Status last verified
- Jun 2026
- First submitted
- 3 May 2024
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Blinded Multi-Center Study to Show the Safety and Effectiveness of the Demetech Barbed PDO Suture
- ClinicalTrials.gov ID
- NCT06404372
- Acronym / sponsor ID
- CF-CLT-PRT
- Conditions
- Wrinkle
- Keywords
- Suture, Sutura, Demetech Barbed PDO Suture, Novathreads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sutura Medical Technology LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial, sponsored by Sutura Medical Technology, Inc., is a pivotal, blinded, multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture, an absorbable Polydioxanone suture, for the temporary treatment of midface wrinkles. The trial will enroll 57 subjects across up to four sites, following them over a 12-month period to evaluate improvements in wrinkles based on the Lemperle Classification Facial Wrinkle Scale. Primary endpoints include assessing the rate of adverse events and a significant reduction in wrinkle severity at 6 months, with secondary endpoints focusing on longer-term results and patient satisfaction.
Detailed description
The study will be a pivotal, blinded, multi-center study to evaluate the safety and effectiveness of Demetech Barbed PDO Suture for the treatment of mid face wrinkles. Subjects who meet Inclusion/Exclusion criteria will receive treatment with Demetech Barbed PDO Sutures. Fifty-seven subjects will be treated. In addition, up to 2 run-in subjects may be treated with Demetech Barbed PDO Sutures by the investigator to allow the investigator to become familiar with Demetech Barbed PDO Suture characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort.
Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 12 months after treatment. Subjects will be followed up for safety via telephone or email at 72 hours after receiving treatment.
The primary effectiveness endpoint will be determined by the proportion of subjects with ≥1 point improvement on the Lemperle Classification of Facial Wrinkles Scale at 6 months compared to baseline as rated by a panel of three blinded evaluators. The Lemperle Scale will be used for photographic assessment by the blinded panel. Assessment of the secondary effectiveness endpoints will include the use of the Lemperle Scale by photograph by the blinded panel and live by the Investigator, as well as Investigator- and Subject-rated GAIS, and FACE-Q.
Safety will be assessed at each follow-up visit. Subjects will be seen for follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Demetech Barbed PDO Suture | Experimental | Device: Demetech Barbed PDO SutureSubjects who meet Inclusion/Exclusion criteria will receive treatment with Demetech Barbed PDO Sutures. Fifty-seven subjects will be treated. In addition, up to 2 run-in subjects may be treated with Demetech Barbed PDO Sutures by the investigator to allow the investigator to become familiar with Demetech Barbed PDO Suture characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects, 22+ years of age.
- 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.
- 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.
- If a woman of childbearing potential, subject confirms she will utilize at least one form of contraception throughout the duration of the study.
- Subjects who desire cheek lifting to correct age-related wrinkles in the midface as recommended by the treating investigator.
Key exclusion criteria (35 listed)
- Abnormal rating in midface sensation, with inability to feel a 0.4 G monofilament or a cotton wisp at any site on the midface.
- Active acne or prominent acne scars in the treatment area.
- Active inflammatory or infectious conditions.
- Allergy or foreign body sensitivities to plastic biomaterials.
- Known bleeding disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demetech Barbed PDO SutureThe Demetech Barbed PDO Suture will be used for the correction of midface wrinkles in all patients enrolled in this study. | Device | Demetech Barbed PDO Suture |
Primary outcome
Improvement From Baseline on the Lemperle Classification Wrinkle Scale
Time frame: 6 Month
The primary effectiveness endpoint is the percentage of subjects with ≥1 point improvement on the Lemperle Classification Facial Wrinkle Scale at 6 months compared to baseline, as rated by a panel of three blinded evaluators. The median score as rated by the blinded panel using subject photographs will be used to determine if a subject is a responder. Clinical effectiveness will be demonstrated by superiority of this 6-month response rate over a target rate of 60%
8 secondary outcomes
Percentage of Subjects With ≥1 Point Change From Baseline on the Lemperle Classification Facial Wrinkle Scale
Time frame: 3, 9, and 12 Months
Change From Baseline on the Lemperle Classification Facial Wrinkle Scale as Rated by a Panel of Three Blinded Evaluators
Time frame: 3 and 6 Month
Percentage of Subjects With ≥1 Point Change From Baseline on the Lemperle Classification Facial Wrinkle Scale
Time frame: 3, 6, 9, and 12 Months
Change From Baseline on the Lemperle Classification Facial Wrinkle Scale as Rated by the Investigator
Time frame: 3, 6, 9, and 12 Months
Responders on Investigator-rated Global Aesthetic Improvement Scale (GAIS)
Time frame: 6 Weeks, 3, 6, 9, 12 Months
Responders on Subject-rated Global Aesthetic Improvement Scale (GAIS)
Time frame: 6 Weeks, 3, 6, 9, 12 Months
FACE-Q Age Appraisal as Rated by the Subject.
Time frame: 6 Weeks, 3, 6, 9, 12 Months
FACE-Q Satisfaction With Cheeks
Time frame: 6 weeks, 3, 6, 9 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherly Soleiman, MD principal investigator
Cosmetic Injectables Center
Chaitali Nangrani, MD principal investigator
Vedas Med Spa
Kristin Tarbet, MD principal investigator
Dr. Kristin Tarbet Facial Plastic Surgery
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demetech Barbed PDO Suture in people with Wrinkle, run by Sutura Medical Technology LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement From Baseline on the Lemperle Classification Wrinkle Scale (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.