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Safety and Effectiveness of PN40082 for Lip Augmentation
trial testing PN40082 in Lip Augmentation in 158 participants. Completed in 3 May 2019.
| Lead sponsor | Prollenium Medical Technologies Inc. |
|---|---|
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 158 |
| Start date | 13 July 2018 |
| Primary completion | 3 May 2019 |
| Estimated completion | 3 May 2019 |
| Sites | 1 location across United States |
Prollenium Medical Technologies Inc.
21 and older, any sex, with Lip Augmentation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)
| Group | Value | 95% CI |
|---|---|---|
| PN40082 | 1.52 | ± .885 |
| Restylane Silk | 1.53 | ± .790 |
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)
| Group | Value | 95% CI |
|---|---|---|
| PN40082 | 49 | |
| Restylane Silk | 51 |
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)
| Group | Value | 95% CI |
|---|---|---|
| PN40082 | 14 | |
| Restylane Silk | 12 |
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)
| Group | Value | 95% CI |
|---|---|---|
| PN40082 | 1.37 | ± .917 |
| Restylane Silk | 1.42 | ± .712 |
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)
| Group | Value | 95% CI |
|---|---|---|
| PN40082 | 1.00 | ± .727 |
| Restylane Silk | .93 | ± .634 |
Time frame: Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | PN40082 | Restylane Silk |
|---|---|---|---|
| Detached Retina Right Eye | Eye disorders | — | — |
| Right Invasive Mammary Carcinoma, Stage 2 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Facial Paralysis | Nervous system disorders | — | — |
| Reaction | System | PN40082 | Restylane Silk |
|---|---|---|---|
| Injection Site Swelling | General disorders | — | — |
| Injection Site Bruising | General disorders | — | — |
| Injection Site Pain | General disorders | — | — |
| Facial Asymmetry | Musculoskeletal and connective tissue disorders | — | — |
| Injection Site Mass | General disorders | — | — |
| Injection Site Erythema | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Injection Site Movement Impairment | General disorders | — | — |
| Injection Site Pruritus | General disorders | — | — |
Most-reported serious reactions: Detached Retina Right Eye, Right Invasive Mammary Carcinoma, Stage 2, Facial Paralysis.
Data from ClinicalTrials.gov NCT04032977 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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