Lip AugmentationPhase 3NCT04029519

A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation

A Phase 3 study testing PN40082 in people with Lip Augmentation, run by Prollenium Medical Technologies Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and efficacy of retreatment with PN40082 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: 84 participants
Where: 6 sitesUnited States
Study dates: 21 Dec 2018to 27 Aug 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

In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all inclusion/exclusion criteria; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2, and had no significant protocol violations that would affect the treatment evaluation.
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

1. Women who are pregnant, lactating, or planning a pregnancy

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

California Dermatology & Clinical Research Institute
Encinitas, California, 92024
International Dermatology Research, Inc
Miami, Florida, 33144
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Schweiger Dermatology, PLLC
New York, New York, 10022
Skin Specialists, PC
Omaha, Nebraska, 68144
Skintastic
Plano, Texas, 75093

Other trials in United States

About this study

To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.

Read the detailed description

This is a multicenter, open-label 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). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with PN40082

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
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.

Study groups in NCT04029519
Study group	Role	What they receive
PN40082	Experimental	All subjects in this study will receive one open-label treatment with PN40082. Receives: Device: PN40082

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Lip Fullness Grading Scale
Lip Fullness Grading Scale is a validated 5-point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 full lips (best outcome)
Measured: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Change From Baseline in Perioral Lines Severity Scale
Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome).
Measured: Visit 1/Day 1 to Visit 3/Month 2, 56 Days

Secondary outcomes (3)

Number of Participants With Patient Global Aesthetic Improvement
Change from baseline for the patient Global Aesthetic Improvement scale, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 very much improved optimal cosmetic result (better outcome)
Measured: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Number of Participants With Investigator Global Aesthetic Improvement
Change from baseline in the Investigator Global Aesthetic Improvement score, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 = very much improved optimal cosmetic result (better outcome)
Measured: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Number of Subjects With Decreased Swelling
Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome)
Measured: Visit 1/Day 1 to Visit 3/Month 2, 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 201827 Aug 2019

First posted23 Jul 2019
Study start21 Dec 2018
Primary completion27 Aug 2019
Study completion27 Aug 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
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04029519
Sponsor's protocol ID: PRO 2018-03
Status last verified: Jun 2021
First submitted: 18 Jul 2019
Last updated: 14 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
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Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
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Clinical Investigation on Lips Treated With HA-filler
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Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
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Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
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All Lip Augmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
ClinicalTrials.gov ID: NCT04029519
Acronym / sponsor ID: PRO 2018-03
Conditions: Lip Augmentation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Prollenium Medical Technologies Inc.Industry (pharma, biotech, devices)
Collaborators: Symbio, LLC
Study start: 21 Dec 2018 (actual)
Primary completion: 27 Aug 2019 (actual)
Study completion: 27 Aug 2019 (actual)
First posted: 23 Jul 2019 (actual)
Results: Posted 14 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 evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation

Arm	Type	Receives
PN40082	Experimental	Device: PN40082All subjects in this study will receive one open-label treatment with PN40082.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all inclusion/exclusion criteria; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2, and had no significant protocol violations that would affect the treatment evaluation.
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 (1 listed)

1. Women who are pregnant, lactating, or planning a pregnancy

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
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.	Device	PN40082

Primary outcome

Change From Baseline in Lip Fullness Grading Scale
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Lip Fullness Grading Scale is a validated 5-point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 full lips (best outcome)
Change From Baseline in Perioral Lines Severity Scale
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome).

3 secondary outcomes

Number of Participants With Patient Global Aesthetic Improvement
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Number of Participants With Investigator Global Aesthetic Improvement
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Number of Subjects With Decreased Swelling
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 days

Results and safety

Results posted to the registry on 14 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PN40082	84	79

Primary outcome: Change From Baseline in Lip Fullness Grading Scale

Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days. Mean (Standard Deviation). Unit: score on a scale

Measure	PN40082 n = 79
Value	.82 (0.747)

Population analysed: Change from Baseline in Overall Lips Fullness Grading Scale at Visit3/Month 2.

Primary outcome: Change From Baseline in Perioral Lines Severity Scale

Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days. Mean (Standard Deviation). Unit: score on a scale

Measure	PN40082 n = 17
Value	-0.75 (0.577)

Population analysed: Change from baseline to Visit 3/Month 2 in the perioral lines rating scale for the 17 subjects who had perioral lines treated.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PN40082	1 of 84 (1.2%)	61 of 84 (72.6%)	0 of 84

Limitations and caveats (from the sponsor): There were no limitations of the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Lip Augmentation

Recruiting
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
Lip Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Active, not recruiting
Clinical Investigation on Lips Treated With HA-filler
Aesthetic Correction of the Lips
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation

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 principal investigator

California Dermatology & Clinical Research Institute

6 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 6 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 3 inclusion and 1 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 14 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 6 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 14 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 From Baseline in Lip Fullness Grading Scale (time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04029519.

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 14 Jul 2021.