Overview

This trial has been completed.

Condition skin roughness
Treatment vyc-12 ha injectable gel
Phase phase 4
Sponsor Allergan
Start date September 2015
End date January 2016
Trial size 134 participants
Trial identifier NCT02877069, V12-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
vyc-12 ha injectable gel
VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.

Primary Outcomes

Measure
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

Measure
Change from Baseline in Instrument Measures of Cheek Skin Smoothness
time frame: Baseline, Month 1
Change from Baseline in Instrument Measures of Cheek Skin Hydration
time frame: Baseline, Month 1
Change from Baseline in Instrument Measures of Cheek Skin Elasticity
time frame: Baseline, Month 1

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Allergan.