A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw
This trial is active, not recruiting.
|Treatment||hyaluronic acid injectable gel|
|Start date||February 2015|
|End date||February 2016|
|Trial size||120 participants|
|Trial identifier||NCT02559908, V25L-001|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Paris, France||Cabinet medical Solferino||no longer recruiting|
|Toulouse, France||Centre de Chirurgie Esthetique||no longer recruiting|
|Bochum, Germany||Hautzentrum Altenbochum - RuhrDERM Gemeinschaftspraxis Dr. med. Ardabili - Dr. med. Niesmann||no longer recruiting|
|Cologne, Germany||Dermatolgie Köln am Rhein||no longer recruiting|
|Darmstadt, Germany||Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH||no longer recruiting|
|Kassel, Germany||Rotes Kreuz Krankenhaus Kassel Gemeinnützige GmbH Klinik für Plastische, Rekonstruktive und Ästhetische Chirurgie||no longer recruiting|
|Munich, Germany||Praxisgemeinschaft Theatiner46 Dres. Ogilvie und Dr. Bernd Schuster||no longer recruiting|
|Wuppertal, Germany||Dermatogische Privatpraxis CentroDerm GmbH||no longer recruiting|
|Amsterdam, Netherlands||Kliniek Dokter Frodo Gaymans||no longer recruiting|
|Amsterdam, Netherlands||Joost Kroon Cosmetische Kliniek||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle
time frame: Baseline, Month 3
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
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
Male or female participants at least 18 years old.
- 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.
|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|
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