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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2019-08-27

Brief Summary

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

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Detailed Description

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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

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Lip Augmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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PN40082

All subjects in this study will receive one open-label treatment with PN40082.

Group Type EXPERIMENTAL

PN40082

Intervention Type 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.

Interventions

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PN40082

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.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

2. 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
3. Willing to give written informed consent

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes