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

Skin Roughness Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877069
• Other study ID #: V12-001
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2016
• Last updated: October 20, 2016
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Skin Roughness

Intervention

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

Locations

Country	Name	City	State
France	Laboratoire Dermscan-Pharmascan	Lyon	Auvergne-Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with a =1 Point Improvement in the 5-Point Allergan Skin Roughness Scale (ASRS) compared to Baseline		Baseline, Month 1	No
Secondary	Change from Baseline in Instrument Measures of Cheek Skin Smoothness		Baseline, Month 1	No
Secondary	Change from Baseline in Instrument Measures of Cheek Skin Hydration		Baseline, Month 1	No
Secondary	Change from Baseline in Instrument Measures of Cheek Skin Elasticity		Baseline, Month 1	No

External Links

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