N/A
N=333
Restylane-L for Correction of Infraorbital Hollows
Infraorbital Hollows
Bottom Line
View on ClinicalTrials.gov: NCT04154930 ↗Enrolled (actual)
333
Serious AEs
1.2%
Results posted
Apr 2023
Primary outcome: Primary: Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS) — 87.4; 17.7 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane-L® (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS) |
87.4; 17.7 | <0.001 sig |
| SECONDARY Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment |
86.0; 13.5; 77.6; 11.1; 63.5; 11.1 | <0.001 sig |
| SECONDARY Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment |
93.0; 2.9; 95.0; 2.6; 91.8; 0 | — |
| SECONDARY Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment |
97.4; 2.9; 97.7; 5.1; 95.3; 10.8 | — |
Summary
This is a prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows.
Eligibility Criteria
Inclusion Criteria
- Moderate or severe infraorbital hollows with no more than one grade difference between the left and right side at baseline as assessed by the blinded evaluator.
- Males or non-pregnant, non-breastfeeding females, over the age of 21.
- Intent to undergo correction of both orbital hollows.
Exclusion Criteria
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
- Previous deep and/or superficial facial dermal therapies.
- Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.
Data sourced from ClinicalTrials.gov (NCT04154930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.