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

NCT02877069 | Completed Phase 4

• 1 other identifier: V12-001
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Roughness

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with a ≥1 Point Improvement in the 5-Point Allergan Skin Roughness Scale (ASRS) compared to Baseline

  Baseline, Month 1

Secondary Outcomes (3)

• 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

• Change from Baseline in Instrument Measures of Cheek Skin Elasticity

  Baseline, Month 1

Study Arms (1)

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

Interventions

VYC-12 HA injectable gel DEVICE

VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.

VYC-12 Injectable Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Laboratoire Dermscan-Pharmascan

Lyon, Auvergne-Rhône-Alpes, 69 100, France

Location

Related Links

• More Information

Study Officials

• Nikki Amaratunge

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

FR (1)