NCT02703948

Brief Summary

This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

August 26, 2022

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

March 3, 2016

Results QC Date

January 25, 2018

Last Update Submit

August 24, 2022

Conditions

Lip Augmentation and Correction of Perioral Rhytids

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine

    12 weeks

Study Arms (1)

Restylane Silk with Lidocaine

OTHER
Device: Restylane Silk with Lidocaine

Interventions

Restylane Silk with LidocaineDEVICE
Restylane Silk with Lidocaine

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
  • Males or females, 22 years of age or older
  • Subjects seeking augmentation therapy for the lips.

You may not qualify if:

  • History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
  • History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents
  • Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

United States, California

Beverly Hills, California, United States

Location

United States, California

San Diego, California, United States

Location

United States, Florida

Miami, Florida, United States

Location

United States, Georgia

Roswell, Georgia, United States

Location

Results Point of Contact

Title
US A&C Clinical Operations
Organization
Galderma R&D, LLC
courtney.maguire@galderma.com
8179615111

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 9, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 26, 2022

Results First Posted

May 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)