Safety and Performance of PTMC Dermal Filler

Not Applicable

Not yet recruiting

• Conditions: Moderate to Severe Nasolabial Fold
• Interventions: Device: PTMC Dermal Filler

• Registration Number: NCT06316479
• Lead Sponsor: Aqpha Medical B.V.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Study Start: 2024-08
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	PTMC Dermal Filler	All participants will receive PTMC Dermal Filler.

Primary Outcome Measures

Name	Time	Method
Nasolabial fold severity	6 months after treatment	The nasolabial fold severity is measured using the Wrinkles Severity Rating Scale (WSRS) by the investigator.

Secondary Outcome Measures

Name	Time	Method
Responder rate	1, 3, 6, 9, 12, and 18 months after treatment	Number of subjects having at least 1-point improvement in the WSRS score compared to the baseline.
Nasolabial fold severity	1, 3, 9, 12, and 18 months after treatment	Mean change from baseline of the nasolabial fold severity measured using the WSRS by the investigator.
Safety (Adverse events)	until 18 months after treatment	Safety is assessed by the collection of adverse events (incidence and severity), and through subject assessment of injection site responses (ISRs) up to 4 weeks after treatment.
Overall aesthetic improvement (by the investigator)	1, 3, 6, 9, 12, and 18 months after treatment	Overall aesthetic improvement is assessed by the investigator using the Global Aesthetic Improvement Scale (GAIS).
Subject satisfaction	1, 3, 6, 9, 12, and 18 months after treatment	Subject satisfaction is measured using a FACE-Q questionnaire.
Overall aesthetic improvement (by the subject)	1, 3, 6, 9, 12, and 18 months after treatment	Overall aesthetic improvement assessed by the subject using the Global Aesthetic Improvement Scale (GAIS).