## Protocol Section
### Identification Module
**NCT ID:** NCT06316479

**Brief Title:** Safety and Performance of PTMC Dermal Filler

**Official Title:** A Prospective, Multi-Centre, Single-Arm First-In-Man Study to Evaluate the Safety and Performance of PTMC Dermal Filler for the Correction of Moderate to Severe Nasolabial Folds

#### Organization Study ID Info
**ID:** CI-001-23
#### Organization
**Class:** INDUSTRY
**Full Name:** Aqpha Medical B.V.
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-18

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-03-18
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-12
**Study First Submit QC Date:** 2024-03-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Aqpha Medical B.V.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Moderate to Severe Nasolabial Fold

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All participants will receive PTMC Dermal Filler.

**Intervention Names:**

- Device: PTMC Dermal Filler

**Label:** Treatment group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment group

**Description:** 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.

**Name:** PTMC Dermal Filler

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Evaluation of pain by the participant using Visual Analog Scale (VAS)

**Measure:** Visual Analog Scale (VAS) for pain

**Time Frame:** After each injection and at the 2-weeks follow-up visit

**Description:** Treatment satisfaction evaluated by the subject using a questionnaire.

**Measure:** Treatment satisfaction

**Time Frame:** 1, 3, 6, 9, 12, and 18 months after treatment

**Description:** Ease of use of the device evaluated by the investigator using a questionnaire.

**Measure:** Ease of use

**Time Frame:** After injection of the device on day 0

#### Primary Outcomes

**Description:** The nasolabial fold severity is measured using the Wrinkles Severity Rating Scale (WSRS) by the investigator.

**Measure:** Nasolabial fold severity

**Time Frame:** 6 months after treatment

#### Secondary Outcomes

**Description:** 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.

**Measure:** Safety (Adverse events)

**Time Frame:** until 18 months after treatment

**Description:** Mean change from baseline of the nasolabial fold severity measured using the WSRS by the investigator.

**Measure:** Nasolabial fold severity

**Time Frame:** 1, 3, 9, 12, and 18 months after treatment

**Description:** Number of subjects having at least 1-point improvement in the WSRS score compared to the baseline.

**Measure:** Responder rate

**Time Frame:** 1, 3, 6, 9, 12, and 18 months after treatment

**Description:** Overall aesthetic improvement is assessed by the investigator using the Global Aesthetic Improvement Scale (GAIS).

**Measure:** Overall aesthetic improvement (by the investigator)

**Time Frame:** 1, 3, 6, 9, 12, and 18 months after treatment

**Description:** Overall aesthetic improvement assessed by the subject using the Global Aesthetic Improvement Scale (GAIS).

**Measure:** Overall aesthetic improvement (by the subject)

**Time Frame:** 1, 3, 6, 9, 12, and 18 months after treatment

**Description:** Subject satisfaction is measured using a FACE-Q questionnaire.

**Measure:** Subject satisfaction

**Time Frame:** 1, 3, 6, 9, 12, and 18 months after treatment

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 67 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
