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Completed

NCT Number: NCT02877069

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

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.

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Key information

Conditions

Skin Roughness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laboratoire Dermscan-Pharmascan

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VYC-12 HA injectable gel

Device

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

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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Prospective, Single-arm Study of the Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions Such as Fine Lines and for Improvement of Skin Quality

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2016
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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