Lip AugmentationPhase 3NCT04029545
A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation
A Phase 3 study testing PN40082 in people with Lip Augmentation, run by Prollenium Medical Technologies Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of repeat injections and pain associated with injection of PN40082 and comparative pain associated with RV001 with a topical anesthetic and RV001 for lip augmentation. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Jun 2019to 9 Dec 2019
- Phase
- Phase 3
- 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
- Completed Protocol PRO 2018-03 OR Protocol PRO 2018-02 and did not enroll in Protocol PRO 2018-03.
- Men or non-pregnant or non-breastfeeding women over 21 years of age
- At PRO 2018-02 baseline visit had 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 Had 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
- If female and of childbearing potential, a negative urine pregnancy test at Visit 1/Day 1 and the subject agrees to use adequate contraception during the study period.
- Willing to give written informed consent.
Who cannot join
- Women who are pregnant, lactating, or planning a pregnancy.
- Subjects with a known history of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or to latex.
- Subjects with a significant ongoing adverse event from PRO 2018-02 or PRO 2018-03 that in the opinion of the investigator could be worsened by participation in this study.
- Subjects that experienced an SAE, AESI, visual changes or other serious medical conditions during PRO 2018-02 or PRO 2018-03
- Subjects who are unable to withhold 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 before AND after any injection session.
- Subjects with 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.
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- Subjects with lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments.
- Subjects with abnormal lip function, with inability to effectively sip water through a straw.
- Subjects with abnormal lip sensation with inability to feel a 0.4G monofilament or a cotton wisp at any site on the lip.
- Subjects with moderate or severe abnormal lip asymmetry.
- Subjects with any mass formation on the lip.
- Subjects with 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.
- Subjects that have undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, polyacrylamide, lifting threads) anywhere in the face or neck, or are planning to be implanted with any of these products during the study.
- Subjects that have 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 are planning to undergo such treatment during the study.
- Subjects that have 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 are planning to undergo any of these procedures during the study.
- that have used ANY lip filling agents within 12 months of study enrollment (hyaluronic acid products, collagen-based products, etc.) other than Investigational Device administered in PRO 2018-02 and PRO-2018-03.
- Subjects that have used any lip plumping products or devices within 10 days before enrollment or are planning to use such products during the study.
- Subjects that have 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 are 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).
- Subjects that have a history or presence of bleeding disorders.
- Subjects that have used systemic corticosteroids or immunosuppressive medications within 30 days prior to treatment.
- Subjects that are on a concurrent regimen of lidocaine or structurally related local anesthetics (e.g., bupivacaine)
- Subjects that have an active inflammation (skin eruptions such as cysts, pimples, rashes, or hives), infection cancerous or precancerous lesion, or unhealed wound on the face.
- Subjects that have a history of known susceptibility to keloid formation or hypertrophic scars.
- Subjects that have porphyria.
- Subjects that have active herpes labialias 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.
- Subjects that have 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.
- Subjects that have any uncontrolled disease, i.e., a condition that has not been appropriately diagnosed, evaluated, and received medically appropriate treatment or care
- Subjects that have 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.
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Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
International Dermatology Research, Inc
Miami, Florida, 33144
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Skin Specialists, PC
Omaha, Nebraska, 68144
Skintastic
Plano, Texas, 75093
About this study
The purpose of this study is to evaluate the safety of repeat injections and pain associated with injection of PN40082 and comparative pain associated with RV001 with a topical anesthetic and RV001 for lip augmentation.
Read the detailed description
This is a multicenter, double-blind, randomized, controlled, roll-over retreatment clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977), and PN40082 in prior Protocol PRO 2018-03 (NCT04029519). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with either RV001, RV001 with a topical anesthetic, or PN40082. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.
- Conditions
- Lip Augmentation
- Being tested
- PN40082
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN40082Device
1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
| Study group | Role | What they receive |
|---|---|---|
| PN40082 | Experimental | 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. The study device will be provided by the Sponsor. Receives: Device: PN40082 |
| RV001 with lidocaine cream | Active comparator | RV001 (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 to be used with LMX4, a topical lidocaine. The study device will be provided by the Sponsor. LMX4 will be provided in commercial stock packaging by the Sponsor Receives: Device: PN40082 |
| RV001 | Experimental | RV001 (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 to be used alone. The study device will be provided by the Sponsor. Receives: Device: PN40082 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Improved Pain Score From Baseline at Visit 2
Compare subject pain scores with a 100 mm visual analog scale with 00 being no pain (better outcome) and 100 being worst possible pain (worse outcome)
Measured: Visit 1/Day 1 through Visit 2/Month 1, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start14 Jun 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Why it stopped: The study was placed on hold for the FDA review of revisions of the protocol. Review time resulted in roll-over subjects to be out of window for enrollment.
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
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, double-blind, randomized, controlled, roll-over retreatment clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977), and PN40082 in prior Protocol PRO 2018-03 (NCT04029519). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with either RV001, RV001 with a topical anesthetic, or PN40082. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prollenium Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Responsible party
- Sponsor
- Investigators
- Stacy R Smith, MD, Study director, California Dermatology & Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029545
- Sponsor's protocol ID
- PRO 2019-02
- Status last verified
- May 2021
- First submitted
- 18 Jul 2019
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation
- ClinicalTrials.gov ID
- NCT04029545
- Acronym / sponsor ID
- PRO 2019-02
- Conditions
- Lip Augmentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was placed on hold for the FDA review of revisions of the protocol. Review time resulted in roll-over subjects to be out of window for enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Prollenium Medical Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 20 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of repeat injections and pain associated with injection of PN40082 and comparative pain associated with RV001 with a topical anesthetic and RV001 for lip augmentation.
Detailed description
This is a multicenter, double-blind, randomized, controlled, roll-over retreatment clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977), and PN40082 in prior Protocol PRO 2018-03 (NCT04029519). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with either RV001, RV001 with a topical anesthetic, or PN40082. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a multicenter, double-blind, randomized, controlled, roll-over retreatment clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977), and PN40082 in prior Protocol PRO 2018-03 (NCT04029519). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with either RV001, RV001 with a topical anesthetic, or PN40082. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.
| Arm | Type | Receives |
|---|---|---|
| PN40082 | Experimental | Device: PN40082PN40082 (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. The study device will be provided by the Sponsor. |
| RV001 with lidocaine cream | Active comparator | Device: PN40082RV001 (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 to be used with LMX4, a topical lidocaine. The study device will be provided by the Sponsor. LMX4 will be provided in commercial stock packaging by the Sponsor |
| RV001 | Experimental | Device: PN40082RV001 (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 to be used alone. The study device will be provided by the Sponsor. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed Protocol PRO 2018-03 OR Protocol PRO 2018-02 and did not enroll in Protocol PRO 2018-03.
- Men or non-pregnant or non-breastfeeding women over 21 years of age
- At PRO 2018-02 baseline visit had 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 Had 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
- If female and of childbearing potential, a negative urine pregnancy test at Visit 1/Day 1 and the subject agrees to use adequate contraception during the study period.
- Willing to give written informed consent.
Key exclusion criteria (29 listed)
- Women who are pregnant, lactating, or planning a pregnancy.
- Subjects with a known history of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or to latex.
- Subjects with a significant ongoing adverse event from PRO 2018-02 or PRO 2018-03 that in the opinion of the investigator could be worsened by participation in this study.
- Subjects that experienced an SAE, AESI, visual changes or other serious medical conditions during PRO 2018-02 or PRO 2018-03
- Subjects who are unable to withhold 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 before AND after any injection session.
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 |
|---|---|---|
| PN400821.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. | Device | PN40082, RV001, RV001 with lidocaine cream |
Primary outcome
Number of Participants With Improved Pain Score From Baseline at Visit 2
Time frame: Visit 1/Day 1 through Visit 2/Month 1, 28 days
Compare subject pain scores with a 100 mm visual analog scale with 00 being no pain (better outcome) and 100 being worst possible pain (worse outcome)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stacy R Smith, MD study director
California Dermatology & Clinical Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PN40082 in people with Lip Augmentation, run by Prollenium Medical Technologies Inc. at 5 sites 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 5 inclusion and 29 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: stopped early, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 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?
Number of Participants With Improved Pain Score From Baseline at Visit 2 (time frame: Visit 1/Day 1 through Visit 2/Month 1, 28 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 20 Aug 2021.