Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions
NCT ID: NCT02877069
Last Updated: 2016-10-21
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
PHASE4
134 participants
INTERVENTIONAL
2015-09-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VYC-12 Injectable Gel
VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection on Day 0 in the face and if applicable neck areas. Participants are eligible to receive up to 3 treatments including an optional top-up and an optional second treatment.
VYC-12 HA injectable gel
VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.
Interventions
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VYC-12 HA injectable gel
VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Nikki Amaratunge
Role: STUDY_DIRECTOR
Allergan
Locations
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Laboratoire Dermscan-Pharmascan
Lyon, Auvergne-Rhône-Alpes, France
Countries
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Related Links
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More Information
Other Identifiers
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V12-001
Identifier Type: -
Identifier Source: org_study_id
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