Safety and Effectiveness of VYC-12 Hyaluronic Acid Inject... | NCT02877069

NCT02877069

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VYC-12 Injectable Gel	Experimental	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.	Device: VYC-12 HA injectable gel

Name	Type	Description	Arm Group Labels	Other Names
VYC-12 HA injectable gel	Device	VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.	VYC-12 Injectable Gel

Measure	Description	Time Frame
Percentage of Participants with a ≥1 Point Improvement in the 5-Point Allergan Skin Roughness Scale (ASRS) compared to Baseline		Baseline, Month 1

Measure	Description	Time Frame
Change from Baseline in Instrument Measures of Cheek Skin Smoothness		Baseline, Month 1
Change from Baseline in Instrument Measures of Cheek Skin Hydration		Baseline, Month 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.