Lip AugmentationNCT04032977
Safety and Effectiveness of PN40082 for Lip Augmentation
A study testing PN40082 and Restylane Silk in people with Lip Augmentation, run by Prollenium Medical Technologies Inc. at 1 site in United States.
Trial summary
To compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation in approximately 158 subjects. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- PN40082 and Restylane Silk
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to 3 May 2019
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or non-pregnant or non-breastfeeding women over 21 years of age
- If female and of childbearing potential, a negative urine pregnancy test at Baseline (Day 1) and the subject agrees to use adequate contraception during the study period
- Has an overall score of very thin, or thin on the LFGS, as agreed upon by the Treating and Evaluating Investigators, and desires at least a 1-point improvement in overall LFGS score; OR Has a Fitzpatrick skin phototype IV, V or VI and has an LFGS score of thick or full, as agreed upon by the Treating and Evaluating Investigators, and desires treatment to the vermilion body of 1 or both lips
- Willing to give written informed consent
Who cannot join
- Women who are pregnant, lactating, or planning a pregnancy
- History of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or to latex, or is planning to undergo desensitization therapy during the study
- Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
- Has abnormal lip function, with inability to effectively sip water through a straw
- Has abnormal lip sensation, with inability to feel a 0.4G monofilament or a cotton wisp at any site on the lip
- Has moderate or severe abnormal lip asymmetry
Show all 25Show fewer
- Has any mass formation on the lip
- Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator. Subjects planning to undergo extensive dental procedures such as dental implants, multiple tooth extractions, or oral surgery should not participate. Minor dental procedures such as teeth cleaning and repair of caries are not exclusionary
- Has undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, polyacrylamide, lifting threads) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
- Has undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study
- Has undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower face (below the orbital rim), mesotherapy, or cosmetic procedures in the face or neck (e.g., face-lift, laser, photo-modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, microneedling, or other ablative procedures) within 9 months before enrollment or is planning to undergo any of these procedures during the study
- Has used ANY lip filling agents within 12 months of study enrollment (hyaluronic acid products, collagen-based products, etc.)
- Has used any lip plumping products or devices within 10 days before enrollment or is planning to use such products during the study
- Has begun using any over-the-counter (OTC) or prescription oral or topical anti wrinkle products for the lips or around the mouth within 90 days before enrollment or is planning to begin using such products during the study (Subjects who have been on a stable regimen of such products for at least 90 days are eligible for the study and must continue their regimen throughout the study.)
- Is on an ongoing regimen of anticoagulation therapy (e.g., warfarin), thrombolytics, or inhibitors of platelet aggregation or nonsteroidal anti inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device injections. Subjects who will withhold such therapy for 10 days before AND after any injection session may participate
- Has a history or presence of bleeding disorders
- Has used systemic corticosteroids or immunosuppressive medications within 30 days prior to treatment
- Is on a concurrent regimen of lidocaine or structurally related local anesthetics (e.g., bupivacaine)
- Has an active inflammation (skin eruptions such as cysts, pimples, rashes, or hives), infection, cancerous or precancerous lesion, or unhealed wound on the face
- Has a history of known susceptibility to keloid formation or hypertrophic scars
- Has porphyria
- Has active herpes labialis lesions at the time of injections. Subjects with a history of herpes labialis who have had four (4) or more outbreaks in the 12 months prior to enrollment are also excluded even in the absence of lesions at the baseline visit
- Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction that, in the opinion of the investigator, would place them at risk of associated complications from these illnesses during the course of the study
- Has any uncontrolled disease, i.e., a condition that has not been appropriately diagnosed, evaluated, and received medically appropriate treatment or care
- Has severe cardiovascular disease; examples include but are not limited to New York Heart Association heart failure classification III or IV, unstable angina, and internal pacemakers. Potential subjects with other significant cardiovascular diseases should be discussed with the Medical Monitor before enrolling-
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
Official title: A Multicenter, Double-blind, Randomized, Controlled Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
To compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation in approximately 158 subjects.
Read the detailed description
The objective of the study is to compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation. Approximately 158 subjects will be randomized at approximately 7 sites in this is a double-blind, randomized, controlled, multicenter clinical study of subjects seeking lip augmentation. Subjects meeting inclusion/exclusion criteria will be randomized 1:1 to treatment with either PN40082 or Restylane Silk. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.
At each visit, the blinded Evaluating Investigator evaluations and subject evaluations of the treated areas will be performed and recorded. Visits and telephone contacts will occur at:
Visit 1 / Week 0 (Day 1) - baseline and treatment
- Day 3 (±2 days) - Safety follow-up telephone call
- Day 14 (±2 days) - Safety follow-up telephone call Visit 2 / Day 28 (±2 days) / Month 1 - interim visit (touch-up if necessary)
- Day 33 (±2 days) - Safety follow-up telephone call (for subjects with touch-up treatment
- Day 44 (±2 days) - Safety follow-up telephone call (for subjects with touch-up treatment) Visit 3 / Day 56 (±4 days) / Month 2 - interim visit Visit 4 / Day 84 (±4 days) / Month 3 - interim visit
- Day 112 (±4 days) / Month 4 - Safety follow-up telephone call
- Day 140 (±4 days) / Month 5 - Safety follow-up telephone call Visit 5 / Day 168 (±7 days) / Month 6 - End of Study (EOS) Visit. All subjects will undergo the consent procedure for the open label retreatment protocol.
Evaluations include:
Lip Fullness Grading Scale (LFGS) (Overall lip fullness considering both lips together, fullness of the upper lip and fullness of the lower lip) Perioral lines at rest severity scale (POL) (Overall perioral lines at rest severity considering both lips together, perioral lines at rest severity of the upper lip and perioral lines at rest severity of the lower lip) Patient Global Aesthetic Improvement (pGAI) Investigator Global Aesthetic Improvement (iGAI) Safety will be assessed by monitoring adverse events (AEs) at all study visits
Other Safety Evaluations include:
Lip Function Lip Sensation
Other evaluations include:
Investigator Ease of Use Assessment Swelling Assessment Subject Satisfaction with Lips Assessment Subjects participation will be approximately 6 months and the study is estimated to last 20 months from first subject first visit to last subject last visit.
- Conditions
- Lip Augmentation
- Being tested
- PN40082, Restylane Silk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN40082Device
To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips
Restylane SilkDevice
To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips
| Study group | Role | What they receive |
|---|---|---|
| PN40082 | Experimental | Test device: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w Receives: Device: PN40082; Device: Restylane Silk |
| Restylane Silk | Active comparator | Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. Receives: Device: PN40082; Device: Restylane Silk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overall Lip Fullness Grading Scale
The Lip Fullness Grading Scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 being full lips (better outcome)
Measured: Visit 1 baseline to Visit 3 Month 2, 56 days
Secondary outcomes (4)
Treatment Success Lip Fullness Grading Scale
Percent of subjects with Lip Fullness treatment success (responder: overall LFGS based on the Blinded Evaluating Investigator Assessment) at Visit 3/Month 2 where responder is defined as a subject with at least a 1-grade increase from baseline on the LFGS post augmentation The lip fullness grading scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) to 4 being full lips (better outcome)
Measured: Visit 1 baseline to Visit 3 Month 2, 56 days
Treatment Success Perioral Lines Severity Scale
Percent of responders with Perioral Lines Treatment Success overall on the POL severity scale at Visit 4/Month 3 (defined as a subject demonstrating ≥ 1-point improvement, i.e., decrease in severity, from baseline. The Perioral Lines at rest severity scale is a 4 point rating scale with 0 = None, a mouth with no perioral lines (better outcome) to 3 = Severe, being a mouth with many deep lines or crevices (worse outcome)
Measured: Visit 1 baseline to Visit 4 Month 3, 84 days
Change From Baseline to Visit 4/Month 3 in Overall Lip Fullness Grading Scale
The lip fullness grading scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) to 4 being full lips (better outcome)
Measured: Visit 1 baseline to Visit 4 Month 3, 84 days
Change From Baseline to Visit 5/Month 6 in Overall Lip Fullness Grading Scale
The lip fullness grading scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) to 4 being full lips (better outcome)
Measured: Visit 1 baseline to Visit 5 Month 6, 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start13 Jul 2018
- Primary completion3 May 2019
- Study completion3 May 2019
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 Lip AugmentationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, controlled, multicenter clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prollenium Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032977
- Sponsor's protocol ID
- PRO 2018-02
- Status last verified
- May 2021
- First submitted
- 19 Jul 2019
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Controlled Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
- ClinicalTrials.gov ID
- NCT04032977
- Acronym / sponsor ID
- PRO 2018-02
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Prollenium Medical Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Posted 12 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation in approximately 158 subjects.
Detailed description
The objective of the study is to compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation. Approximately 158 subjects will be randomized at approximately 7 sites in this is a double-blind, randomized, controlled, multicenter clinical study of subjects seeking lip augmentation. Subjects meeting inclusion/exclusion criteria will be randomized 1:1 to treatment with either PN40082 or Restylane Silk. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.
At each visit, the blinded Evaluating Investigator evaluations and subject evaluations of the treated areas will be performed and recorded. Visits and telephone contacts will occur at:
Visit 1 / Week 0 (Day 1) - baseline and treatment
- Day 3 (±2 days) - Safety follow-up telephone call
- Day 14 (±2 days) - Safety follow-up telephone call Visit 2 / Day 28 (±2 days) / Month 1 - interim visit (touch-up if necessary)
- Day 33 (±2 days) - Safety follow-up telephone call (for subjects with touch-up treatment
- Day 44 (±2 days) - Safety follow-up telephone call (for subjects with touch-up treatment) Visit 3 / Day 56 (±4 days) / Month 2 - interim visit Visit 4 / Day 84 (±4 days) / Month 3 - interim visit
- Day 112 (±4 days) / Month 4 - Safety follow-up telephone call
- Day 140 (±4 days) / Month 5 - Safety follow-up telephone call Visit 5 / Day 168 (±7 days) / Month 6 - End of Study (EOS) Visit. All subjects will undergo the consent procedure for the open label retreatment protocol.
Evaluations include:
Lip Fullness Grading Scale (LFGS) (Overall lip fullness considering both lips together, fullness of the upper lip and fullness of the lower lip) Perioral lines at rest severity scale (POL) (Overall perioral lines at rest severity considering both lips together, perioral lines at rest severity of the upper lip and perioral lines at rest severity of the lower lip) Patient Global Aesthetic Improvement (pGAI) Investigator Global Aesthetic Improvement (iGAI) Safety will be assessed by monitoring adverse events (AEs) at all study visits
Other Safety Evaluations include:
Lip Function Lip Sensation
Other evaluations include:
Investigator Ease of Use Assessment Swelling Assessment Subject Satisfaction with Lips Assessment Subjects participation will be approximately 6 months and the study is estimated to last 20 months from first subject first visit to last subject last visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, controlled, multicenter clinical study
| Arm | Type | Receives |
|---|---|---|
| PN40082 | Experimental | Device: PN40082, Device: Restylane SilkTest device: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w |
| Restylane Silk | Active comparator | Device: PN40082, Device: Restylane SilkRestylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or non-pregnant or non-breastfeeding women over 21 years of age
- If female and of childbearing potential, a negative urine pregnancy test at Baseline (Day 1) and the subject agrees to use adequate contraception during the study period
- Has an overall score of very thin, or thin on the LFGS, as agreed upon by the Treating and Evaluating Investigators, and desires at least a 1-point improvement in overall LFGS score; OR Has a Fitzpatrick skin phototype IV, V or VI and has an LFGS score of thick or full, as agreed upon by the Treating and Evaluating Investigators, and desires treatment to the vermilion body of 1 or both lips
- Willing to give written informed consent
Key exclusion criteria (25 listed)
- Women who are pregnant, lactating, or planning a pregnancy
- History of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or to latex, or is planning to undergo desensitization therapy during the study
- Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
- Has abnormal lip function, with inability to effectively sip water through a straw
- Has abnormal lip sensation, with inability to feel a 0.4G monofilament or a cotton wisp at any site on the lip
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 |
|---|---|---|
| PN40082To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips | Device | PN40082, Restylane Silk |
| Restylane SilkTo provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips | Device | PN40082, Restylane Silk |
Primary outcome
Change in Overall Lip Fullness Grading Scale
Time frame: Visit 1 baseline to Visit 3 Month 2, 56 days
The Lip Fullness Grading Scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 being full lips (better outcome)
4 secondary outcomes
Treatment Success Lip Fullness Grading Scale
Time frame: Visit 1 baseline to Visit 3 Month 2, 56 days
Treatment Success Perioral Lines Severity Scale
Time frame: Visit 1 baseline to Visit 4 Month 3, 84 days
Change From Baseline to Visit 4/Month 3 in Overall Lip Fullness Grading Scale
Time frame: Visit 1 baseline to Visit 4 Month 3, 84 days
Change From Baseline to Visit 5/Month 6 in Overall Lip Fullness Grading Scale
Time frame: Visit 1 baseline to Visit 5 Month 6, 168 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PN40082 and Restylane Silk in people with Lip Augmentation, run by Prollenium Medical Technologies Inc. at 1 site 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 4 inclusion and 25 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 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 Jul 2021). 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?
Change in Overall Lip Fullness Grading Scale (time frame: Visit 1 baseline to Visit 3 Month 2, 56 days). 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 12 Jul 2021.