Status:
COMPLETED
A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
Lead Sponsor:
Prollenium Medical Technologies Inc.
Collaborating Sponsors:
Symbio, LLC
Conditions:
Lip Augmentation
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
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 (NCT0403...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 1\. Women who are pregnant, lactating, or planning a pregnancy
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04029519
Start Date
December 21 2018
End Date
August 27 2019
Last Update
July 14 2021
Active Locations (6)
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1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
2
International Dermatology Research, Inc
Miami, Florida, United States, 33144
3
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
4
Schweiger Dermatology, PLLC
New York, New York, United States, 10022