This study will evaluate the safety and effectiveness of VYC-12 hyaluronic acid (HA)
injectable gel for filling fine lines, as measured by skin texture improvement, and for
improvement of skin quality.
Device: VYC-12 HA injectable gel
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Locations near you
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Full eligibility criteria for NCT02877069
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Participants in good general health
Score of 2=Moderate (coarse and uneven visual skin texture) or 3=Severe (coarse visual skin texture, crosshatched fine lines) on both cheeks using the 5-Point Allergan Skin Roughness Scale (ASRS).
Has undergone tissue augmentation with dermal fillers including HA, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg. face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the face or neck within the past 12 months
Has received any crosslinked HA filler in any anatomic area within the past 12 months
Has undergone treatment with botulinum toxins in the face or neck within the past 6 months
Has ever received semi-permanent fillers or permanent facial implants (eg. poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or neck
Has facial hair that would interfere with the visualization of the face or neck
Has undergone a dental procedure within the past 6 weeks
Has a tendency to develop hypertrophic scarring
Has a history of allergy to HA products and/or to gram-positive bacterial proteins as HA is produced by Streptococcus-type bacteria
Has a history of anaphylactic shock
Has been previously diagnosed with streptococcal disease (eg. recurrent sore throat, acute rheumatic fever)
Has current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face or neck
Is on an ongoing regimen of anticoagulation therapy (eg. warfarin)
Is on an ongoing regimen of medications (eg. aspirin, ibuprofen) or other substances
(eg, herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection
Has begun using any over-the-counter or prescription, oral or topical, antiwrinkle products on the face or neck within the past 30 days.
All locations for NCT02877069
Lyon, Auvergne-Rhône-Alpes, France, 69 100
View full eligibility
Tris trial is registered with FDA with number: NCT02877069. The sponsor of the trial is Allergan and it is looking for 134 volunteers for the current phase.
Official trial title: A Prospective, Single-arm Study of the Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions Such as Fine Lines and for Improvement of Skin Quality
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