NCT02559908

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
3 countries

10 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

February 26, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

12 months

First QC Date

September 23, 2015

Last Update Submit

December 11, 2017

Conditions

Chin Retrusion

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle

    Baseline, Month 3

Secondary Outcomes (2)

  • 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)

    Month 3

  • Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS

    Month 3

Study Arms (2)

Treatment Group_VYC-25L

EXPERIMENTAL

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

Control Group_No treatment then VYC-25L

OTHER

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

Interventions

Hyaluronic Acid Injectable GelDEVICE

Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).

Control Group_No treatment then VYC-25LTreatment Group_VYC-25L

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has chin retrusion.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cabinet medical Solferino

Paris, 75007, France

Location

Centre de Chirurgie Esthetique

Toulouse, 31000, France

Location

Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann

Bochum, 44803, Germany

Location

Dermatolgie Köln am Rhein

Cologne, 50996, Germany

Location

Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

Darmstadt, 64283, Germany

Location

Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie

Kassel, 34121, Germany

Location

Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster

Munich, 80333, Germany

Location

Dermatogische Privatpraxis CentroDerm GmbH

Wuppertal, 42287, Germany

Location

Kliniek Dokter Frodo Gaymans

Amsterdam, 1075, Netherlands

Location

Joost Kroon Cosmetische Kliniek

Amsterdam, 1077, Netherlands

Location

Related Links

Study Officials

  • Smita Chawla

    Allergan, plc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

February 26, 2015

Primary Completion

February 12, 2016

Study Completion

December 1, 2017

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

FR(2)DE(6)NL(2)