Clinical trial NCT02559908: A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Retrusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: 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)
timeFrame: Month 3
measure: Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS
timeFrame: Month 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Cabinet medical Solferino
city: Toulouse
country: France
facility: Centre de Chirurgie Esthetique
city: Bochum
country: Germany
facility: Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann
city: Cologne
country: Germany
facility: Dermatolgie Köln am Rhein
city: Darmstadt
country: Germany
facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
city: Kassel
country: Germany
facility: Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie
city: Munich
country: Germany
facility: Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster
city: Wuppertal
country: Germany
facility: Dermatogische Privatpraxis CentroDerm GmbH
city: Amsterdam
country: Netherlands
facility: Kliniek Dokter Frodo Gaymans
city: Amsterdam
country: Netherlands
facility: Joost Kroon Cosmetische Kliniek
Study officials:
affiliation: Allergan, plc
name: Smita Chawla
role: STUDY_DIRECTOR
References: