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

October 20, 2016 updated by: Allergan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Month 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Nikki Amaratunge, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Roughness

Clinical Trials on VYC-12 HA injectable gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe