A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw
NCT ID: NCT02559908
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2015-02-26
2017-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Group_VYC-25L
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
Hyaluronic Acid Injectable Gel
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-25L
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.
Hyaluronic Acid Injectable Gel
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).
Interventions
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Hyaluronic Acid Injectable Gel
Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Smita Chawla
Role: STUDY_DIRECTOR
Allergan, plc
Locations
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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
Countries
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Related Links
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More Information
Other Identifiers
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V25L-001
Identifier Type: -
Identifier Source: org_study_id