Moderate to Severe Nasolabial FoldNCT06316479
Safety and Performance of PTMC Dermal Filler
A study testing PTMC Dermal Filler in people with Moderate to Severe Nasolabial Fold, run by Aqpha Medical B.V..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Nasolabial Fold
- What is being tested?
- PTMC Dermal Filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years and £67 old.
- 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.
- If female and of childbearing potential: a negative urine pregnancy test + agreement to use adequate contraception.
- Ability to understand and comply with the study requirements.
- Willingness and ability to provide written informed consent.
- Agree to refrain from seeking other treatment of nasolabial folds during the study.
- 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.
Who cannot join
- Wrinkle Severity Rating Scale (WSRS) score of ≤ 2 on the right or left nasolabial fold.
- Women who are pregnant or lactating or planning to become pregnant during the study.
- Evidence of scar-related disease or delayed healing activity within the past 1 year.
- History of keloid formation or hypertrophic scars.
- Scars at the intended treatment sites.
- Any infection or wound on the face.
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- Facial tattoo that may interfere with diagnosis.
- Allergic history including anaphylaxis or multiple severe allergies to natural rubber latex or lidocaine.
- 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.
- Aspirin, or nonsteroidal anti-inflammatory drugs within 1 week (7 days) prior to treatment.
- 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.
- Concomitant anticoagulant therapy, antiplatelet therapy, biotherapy or history of bleeding disorders or connective tissue disorders.
- Immunocompromised or immunosuppressed.
- History of autoimmune diseases.
- Anti-covid vaccination (RNA-based vaccines) within 2 weeks (14 days) prior to treatment.
- Received any investigational product within 30 days prior to treatment.
- Received prior dermabrasion, or botulinum toxins under the orbital rim (tear through) within 6 months (180 days) prior to entry into the study.
- Received facelift within 2 years prior to treatment.
- Previous tissue augmentation (bulking agents) for facial wrinkles and scars within 6 months at the mid-face.
- Previous tissue augmentation with permanent implants.
- Treatment of microdermabrasion or micro needling within the whole facial area within 3 months prior to treatment.
- Laser treatment within the whole facial area within 6 months prior to treatment.
About this study
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
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:
Read more
- 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
- Being tested
- PTMC Dermal Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTMC Dermal FillerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | All participants will receive PTMC Dermal Filler. Receives: Device: PTMC Dermal Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasolabial fold severity
The nasolabial fold severity is measured using the Wrinkles Severity Rating Scale (WSRS) by the investigator.
Measured: 6 months after treatment
Secondary outcomes (6)
Safety (Adverse events)
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.
Measured: until 18 months after treatment
Nasolabial fold severity
Mean change from baseline of the nasolabial fold severity measured using the WSRS by the investigator.
Measured: 1, 3, 9, 12, and 18 months after treatment
Responder rate
Number of subjects having at least 1-point improvement in the WSRS score compared to the baseline.
Measured: 1, 3, 6, 9, 12, and 18 months after treatment
Overall aesthetic improvement (by the investigator)
Overall aesthetic improvement is assessed by the investigator using the Global Aesthetic Improvement Scale (GAIS).
Measured: 1, 3, 6, 9, 12, and 18 months after treatment
Overall aesthetic improvement (by the subject)
Overall aesthetic improvement assessed by the subject using the Global Aesthetic Improvement Scale (GAIS).
Measured: 1, 3, 6, 9, 12, and 18 months after treatment
Subject satisfaction
Subject satisfaction is measured using a FACE-Q questionnaire.
Measured: 1, 3, 6, 9, 12, and 18 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Nasolabial FoldStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aqpha Medical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316479
- Sponsor's protocol ID
- CI-001-23
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06316479
- Acronym / sponsor ID
- CI-001-23
- Conditions
- Moderate to Severe Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aqpha Medical B.V.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: PTMC Dermal FillerAll participants will receive PTMC Dermal Filler. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥18 years and £67 old.
- 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.
- If female and of childbearing potential: a negative urine pregnancy test + agreement to use adequate contraception.
- Ability to understand and comply with the study requirements.
- Willingness and ability to provide written informed consent.
Key exclusion criteria (22 listed)
- Wrinkle Severity Rating Scale (WSRS) score of ≤ 2 on the right or left nasolabial fold.
- Women who are pregnant or lactating or planning to become pregnant during the study.
- Evidence of scar-related disease or delayed healing activity within the past 1 year.
- History of keloid formation or hypertrophic scars.
- Scars at the intended treatment sites.
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 |
|---|---|---|
| PTMC Dermal FillerA 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. | Device | Treatment group |
Primary outcome
Nasolabial fold severity
Time frame: 6 months after treatment
The nasolabial fold severity is measured using the Wrinkles Severity Rating Scale (WSRS) by the investigator.
6 secondary outcomes
Safety (Adverse events)
Time frame: until 18 months after treatment
Nasolabial fold severity
Time frame: 1, 3, 9, 12, and 18 months after treatment
Responder rate
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
Overall aesthetic improvement (by the investigator)
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
Overall aesthetic improvement (by the subject)
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
Subject satisfaction
Time frame: 1, 3, 6, 9, 12, and 18 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PTMC Dermal Filler in people with Moderate to Severe Nasolabial Fold, run by Aqpha Medical B.V..
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 7 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Nasolabial fold severity (time frame: 6 months after treatment). 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 18 Mar 2024.