Open Label Pilot Study Evaluating the Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit
Helios Aesthetics Inc.
Summary
The goal of this clinical trial is to study whether the Mosaic Injectable Dermal Implant is a safe and effective treatment for age-related midface volume deficit in adults who are at least 22 years of age. The main questions it aims to answer are: 1. What medical problems do participants have when receiving Mosaic over the 12 months following treatment. 2. How much does Mosaic improve the midface volume at 6 months post-treatment. Participants will: Receive injections to the midface to correct volume deficit. One month from initial injection, if the doctor decides that touch-up injections are required, further injections may be received. Participants will visit the clinic following each injection and at 3, 6 and 12 months post-treatment to have photos taken of their face as a record of their midface volume. Participants will also keep a diary for 30 days following each treatment so that they can record any symptoms that may be linked to the treatment.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Subjects: * Who at baseline, demonstrate bilateral and symmetrical volume deficit in their midface of grades moderate or severe on the CMVDS based upon live image scoring (i.e., both the left and right sides of the face must be graded independently, and both sides must score grades of either moderate or severe to be eligible).. * Who, if male, agree to be clean-shaven at each study visit. Exclusion Criteria: Subjects: * Who are an employee or relative of an employee of the clinical site or study sponsor (e.g., immediate family, household members). * Who may have any ph…