A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw

December 11, 2017 updated by: Allergan

A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of VYC-25L Hyaluronic Acid Injectable Gel for Restoration and Creation of Facial Volume in the Chin and Jaw

This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75007
        • Cabinet medical Solferino
      • Toulouse, France, 31000
        • Centre de Chirurgie Esthetique
  • Germany
      • Bochum, Germany, 44803
        • Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann
      • Cologne, Germany, 50996
        • Dermatolgie Köln am Rhein
      • Darmstadt, Germany, 64283
        • Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
      • Kassel, Germany, 34121
        • Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie
      • Munich, Germany, 80333
        • Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster
      • Wuppertal, Germany, 42287
        • Dermatogische Privatpraxis CentroDerm GmbH
  • Netherlands
      • Amsterdam, Netherlands, 1075
        • Kliniek Dokter Frodo Gaymans
      • Amsterdam, Netherlands, 1077
        • Joost Kroon Cosmetische Kliniek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Has chin retrusion.

Exclusion Criteria:

  • Has ever received or is planning to receive permanent facial implants during the study.
  • Has tattoos, piercings, facial hair or scars that would interfere with visual assessments of the chin or jaw.
  • Has dentures or any device covering part of the palate or plans to undergo any dental procedure other than prophylaxis during the study.
  • Has undergone semipermanent dermal filler treatment to the chin or jaw within 36 months or is planning treatment during the study.
  • Has undergone any surgery of the chin or jaw area within 24 months or a planned surgery during the study.
  • Has undergone mesotherapy, cosmetic resurfacing, or botulinum toxin injections within 6 months or a planned treatment during the study.
  • Has experienced trauma to the chin and jaw area within 6 months.
  • Has been previously diagnosed with streptococcal disease.
  • Has a history of anaphylaxis or allergy to lidocaine, hyaluronic acid or streptococcal protein.
  • Has porphyria or untreated epilepsy.
  • Has active autoimmune disease.
  • Has current cutaneous or mucosal inflammatory or infectious processes, abscess, an unhealed wound, or a cancerous or pre-cancerous lesion.
  • Is on a concurrent regimen of lidocaine or structurally-related local anesthetics or is on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism.
  • Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
  • Is on an ongoing regimen of anti-coagulation therapy.
  • Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances known to increase coagulation time (eg, herbal supplements with garlic or gingko biloba) within the past 10 days.
  • Has begun using any over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment or is planning to begin using such products during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group_VYC-25L
VYC-25L injection into the chin and/or jaw areas on Day 1, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable
Device: Hyaluronic Acid Injectable Gel
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).
Other: Control Group_No treatment then VYC-25L
No treatment for 3 months followed by VYC-25L injection into the chin and/or jaw areas, volume determined by the investigator (up to 4.0 mLs) and repeat treatment if applicable.
Device: Hyaluronic Acid Injectable Gel
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
Time Frame: Baseline, Month 3
Baseline, Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS)
Time Frame: Month 3
Month 3
Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
Time Frame: Month 3
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Smita Chawla, Allergan, plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2015

Primary Completion (Actual)

February 12, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V25L-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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