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OpenTrials
Completed

NCT Number: NCT02703948

Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

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 .

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Key information

Conditions

Lip Augmentation and Correction of Perioral Rhytids

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United States, California, Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Restylane Silk with Lidocaine

Device

Primary outcomes

  1. Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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