Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions

Allergan

Status and phase: Completed; Phase 4

Conditions: Skin Roughness

Treatments: Device: VYC-12 HA injectable gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02877069

V12-001

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

134 participants in 1 patient group

VYC-12 Injectable Gel

Experimental group

Description:

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.

Treatment:

Device: VYC-12 HA injectable gel