Clinical trial NCT04029519: A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
Official title: A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lip Augmentation
Lead sponsor: Prollenium Medical Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Symbio, LLC
First posted: 2019-07-23
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation
Primary purpose: TREATMENT

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 (NCT04032977). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with PN40082

Eligibility criteria: Inclusion Criteria:

1. 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.
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

Exclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline in Lip Fullness Grading Scale
timeFrame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
measure: Change From Baseline in Perioral Lines Severity Scale
timeFrame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Secondary outcomes:
measure: Number of Participants With Patient Global Aesthetic Improvement
timeFrame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
measure: Number of Participants With Investigator Global Aesthetic Improvement
timeFrame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
measure: Number of Subjects With Decreased Swelling
timeFrame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Miami
country: United States
facility: International Dermatology Research, Inc
state: Florida
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: New York
country: United States
facility: Schweiger Dermatology, PLLC
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Plano
country: United States
facility: Skintastic
state: Texas
Study officials:
affiliation: California Dermatology & Clinical Research Institute
name: Stacy R. Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: