Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teoxane SA
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Outpatient, male or female of any race, 22 years of age or older. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
2. Moderate to severe bilateral perioral rhytids (grade 2 or 3 on PR-SRS).
3. Perioral rhytids of the same PR-SRS grade on the left and right sides of the mouth.
4. Able to follow study instructions and complete all required visits.
5. Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.
You may not be if
1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
2. Known hypersensitivity or previous allergic reaction to any component of the study devices.
3. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
4. Clinically significant active skin disease or infection in the perioral area within 6 months prior to study entry (TI discretion).
5. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
6. Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
7. History or presence of condition or feature that may confound the interpretation of the results in the perioral region, for example, tattoo, significant facial hair, acne scaring, prior surgery in the area, potential for active disease or infection flare up such as herpes simplex.
8. History of skin cancer in the treatment area.
9. Elective, clinically significant facial procedures that may confound the interpretation of the results in the perioral region (TI discretion), prior to study enrollment.
10. Clinically active disease or infection in the perioral area or mouth (e.g., dental abscess).
12\. Exposure to any other investigational drug/device within 90 days of entering the study.
13\. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
Clareo Health | RHA® Redensity With New Anesthetic Agent - Perioral Rhytids
