Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

Overview

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lisa Grunebaum, M.D.

Closed for enrollment

Contact information:

Arleth Valencia

(480) 342-6487

Valencia.Arleth@mayo.edu

More information

Publications

Publications are currently not available