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CompletedNCT02877069Updated Oct 21, 2016

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

A Phase 4 interventional study of VYC-12 HA injectable gel in Skin Roughness, sponsored by Allergan. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-21.

Sponsored by Allergan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
134
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Roughness

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 134 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
134 participants (actual)

Study arms

  • Experimental
    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.

    Device: VYC-12 HA injectable gel

Interventions

  • DeviceVYC-12 HA injectable gel

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

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Month 1

Secondary outcomes

  1. Change from Baseline in Instrument Measures of Cheek Skin Smoothness

    Time frame: Baseline, Month 1

  2. Change from Baseline in Instrument Measures of Cheek Skin Hydration

    Time frame: Baseline, Month 1

  3. Change from Baseline in Instrument Measures of Cheek Skin Elasticity

    Time frame: Baseline, Month 1

07

Study locations

1 site
  • Laboratoire Dermscan-Pharmascan
    Lyon, Auvergne-Rhône-Alpes 69 100, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02877069
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Aug 24, 2016
Start date
Sep 2015
Primary completion
Jan 2016
Completion
Oct 2016
Last update
Oct 21, 2016

Study contacts

Nikki Amaratunge
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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