Clinical trial NCT02877069: Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Roughness
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with a ≥1 Point Improvement in the 5-Point Allergan Skin Roughness Scale (ASRS) compared to Baseline
timeFrame: Baseline, Month 1
Secondary outcomes:
measure: Change from Baseline in Instrument Measures of Cheek Skin Smoothness
timeFrame: Baseline, Month 1
measure: Change from Baseline in Instrument Measures of Cheek Skin Hydration
timeFrame: Baseline, Month 1
measure: Change from Baseline in Instrument Measures of Cheek Skin Elasticity
timeFrame: Baseline, Month 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Laboratoire Dermscan-Pharmascan
state: Auvergne-Rhône-Alpes
Study officials:
affiliation: Allergan
name: Nikki Amaratunge
role: STUDY_DIRECTOR
References: