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

Chin Retrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559908
• Other study ID #: V25L-001
• Status: Completed
• Phase: N/A
• First received: September 23, 2015
• Last updated: December 11, 2017
• Start date: February 26, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: December 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2017
• Est. primary completion date: February 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chin Retrusion

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle		Baseline, Month 3
Secondary	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
Secondary	Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS		Month 3

External Links

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