Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT05691972
Sponsor Protocol Number: 43USTH2201
About this study
The purpose of this study is to evaluate the effectiveness of Restylane Contour versus a no-treatment control in correction of temple hollowing by comparing GTVDS response rates.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
- Intent to undergo treatment for correction of temple hollowing.
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 or nerve blocking agents (if intended to be used for that subject).
- Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments.
- Any previous aesthetic procedures or implants.
- Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments.
Eligibility last updated 3/23/23. Questions regarding updates should be directed to the study team contact.
More information
Publications
Publications are currently not available