A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw
- Conditions
- Chin Retrusion
- Registration Number
- NCT02559908
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
-Has chin retrusion.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle Baseline, Month 3
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (10)
Cabinet medical Solferino
🇫🇷Paris, France
Centre de Chirurgie Esthetique
🇫🇷Toulouse, France
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, Germany
Kliniek Dokter Frodo Gaymans
🇳🇱Amsterdam, Netherlands
Joost Kroon Cosmetische Kliniek
🇳🇱Amsterdam, Netherlands
Cabinet medical Solferino🇫🇷Paris, France