Safety and Performance of PTMC Dermal Filler

NCT ID: NCT06316479

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this clinical trial is to assess the safety and performance of the PTMC Dermal filler for treating moderate to severe nasolabial folds in adult men and women.

The main questions it aims to answer are:

• Does the PTMC dermal filler maintain its performance for a minimum of 6 months?
• Is the treatment considered safe for participants?

Participants will:

• Before treatment, the investigator will assess your medical history, medication usage, and satisfaction with your wrinkles/folds.
• You'll receive one injection of the PTMC Dermal filler during your initial visit.
• For 30 days post-injection, you'll keep a diary to note any reactions like pain, redness, or swelling at the injection site.
• At the 1-month follow-up, you can request a 'touch-up' of the filler, extending your participation in the study.
• Participants will visit the clinic a total of 8 times, including the initial treatment and 7 follow-up visits, spanning up to 18 months.
• Each visit will last approximately 60-90 minutes. The visits will be conducted in person.

Conditions

Moderate to Severe Nasolabial Fold

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

All participants will receive PTMC Dermal Filler.

Group Type: EXPERIMENTAL

PTMC Dermal Filler

Intervention Type: DEVICE

A total of 120 subjects will receive treatment with PTMC Dermal Filler. The volume of filler injected will vary depending on the severity of the nasolabial fold. Injections will be administered by the investigator at the beginning of the study, with the injection technique, plane, and volume recorded. Touch-up treatments are permitted at the 1-month follow-up visit, if necessary.

Interventions

PTMC Dermal Filler

A total of 120 subjects will receive treatment with PTMC Dermal Filler. The volume of filler injected will vary depending on the severity of the nasolabial fold. Injections will be administered by the investigator at the beginning of the study, with the injection technique, plane, and volume recorded. Touch-up treatments are permitted at the 1-month follow-up visit, if necessary.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female ≥18 years and £67 old.

2. Two fully visible bilateral nasolabial folds each with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 that may be corrected with an injectable dermal filler.

3. If female and of childbearing potential: a negative urine pregnancy test + agreement to use adequate contraception.

4. Ability to understand and comply with the study requirements.

5. Willingness and ability to provide written informed consent.

6. Agree to refrain from seeking other treatment of nasolabial folds during the study.

7. Over the counter (OTC) wrinkle products or prescription wrinkle treatments, if used, shall be continued throughout the study in similar manner as performed prior to participation.

Exclusion Criteria

1. Wrinkle Severity Rating Scale (WSRS) score of ≤ 2 on the right or left nasolabial fold.

2. Women who are pregnant or lactating or planning to become pregnant during the study.

3. Evidence of scar-related disease or delayed healing activity within the past 1 year.

4. History of keloid formation or hypertrophic scars.

5. Scars at the intended treatment sites.

6. Any infection or wound on the face.

7. Facial tattoo that may interfere with diagnosis.

8. Allergic history including anaphylaxis or multiple severe allergies to natural rubber latex or lidocaine.

9. Clinically significant organic disease including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator preclude participation in the trial.

10. Aspirin, or nonsteroidal anti-inflammatory drugs within 1 week (7 days) prior to treatment.

11. Systemic (oral/injectable) corticosteroids or immunosuppressive medications within 30 days prior to treatment and topical steroids on the face within 14 days prior to trial start and throughout the study.

12. Concomitant anticoagulant therapy, antiplatelet therapy, biotherapy or history of bleeding disorders or connective tissue disorders.

13. Immunocompromised or immunosuppressed.

14. History of autoimmune diseases.

15. Anti-covid vaccination (RNA-based vaccines) within 2 weeks (14 days) prior to treatment.

16. Received any investigational product within 30 days prior to treatment.

17. Received prior dermabrasion, or botulinum toxins under the orbital rim (tear through) within 6 months (180 days) prior to entry into the study.

18. Received facelift within 2 years prior to treatment.

19. Previous tissue augmentation (bulking agents) for facial wrinkles and scars within 6 months at the mid-face.

20. Previous tissue augmentation with permanent implants.

21. Treatment of microdermabrasion or micro needling within the whole facial area within 3 months prior to treatment.

22. Laser treatment within the whole facial area within 6 months prior to treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aqpha Medical B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CI-001-23

Identifier Type: -

Identifier Source: org_study_id