Infra-orbital Skin Depressions Clinical Trial
| Verified date | April 2019 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 3, 2015 |
| Est. primary completion date | August 18, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Has Grade > 0 at screening within each eye (bilateral skin depression in the infra-orbital area), as evaluated by the Evaluating Investigator (EI) using AIRS - Agree to refrain from undergoing other antiwrinkle/volumizing treatments in the upper two-thirds of the face (eyebrow to cheeks/cheekbones) for the duration of the study Exclusion Criteria: - Has undergone cosmetic facial procedures [e.g., face-lift, or other surgeries which may alter the appearance of the infra-orbital area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face, or Vistabel® cosmetic injections in the peri-orbital area, within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 12 months prior to study entry - Has undergone volumizing of the mid face within 12 months prior to study entry - Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the infra-orbital area, or be planning to be implanted with any of these products at any time during the study - Have a history of skin cancer - Have a history of hypertrophic scarring - Have a subcutaneous retaining structure on the face (e.g., meshing, gold strand) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
France,
Niforos F, Acquilla R, Ogilvie P, Safa M, Signorini M, Creutz L, Kerson G, Silberberg M. A Prospective, Open-Label Study of Hyaluronic Acid-Based Filler With Lidocaine (VYC-15L) Treatment for the Correction of Infraorbital Skin Depressions. Dermatol Surg. 2017 Oct;43(10):1271-1280. doi: 10.1097/DSS.0000000000001127. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Subjects With a =1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side | The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe). | Baseline, Month 1 | |
| Secondary | Percentage of Subjects With a =1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side | The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe). | Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12 | |
| Secondary | Injector Ease of Use on an 11-Point Scale | The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy). | Day 0 | |
| Secondary | Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) | The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported. | Day 0, Day 14, Month 1, Month 6, Month 9, Month 12 | |
| Secondary | Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) | The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported. | Day 0, Day 14, Month 1, Month 6, Month 9, Month 12 | |
| Secondary | Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ) | Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject's overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse). | Day 0, Day 14, Month 1, Month 6, Month 9, Month 12 |