Status:
COMPLETED
RHA® 4 With New Anesthetic - Nasolabial Folds
Lead Sponsor:
Teoxane SA
Conditions:
Aging
Pain
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® 4 with New Anesthetic Agent is non-inferior to RHA® 4 (with li...
Eligibility Criteria
Inclusion
- 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.
- Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point WSRS).
- Nasolabial folds of the same WSRS grade on the left and right sides of the face.
- Able to follow study instructions and complete all required visits.
- 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.
Exclusion
- Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
- Known hypersensitivity or previous allergic reaction to any component of the study devices.
- Use of a prohibited treatment/procedure within time periods defined in the protocol
- Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
- History of connective tissue disease.
- Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
- History of skin cancer in the treatment area.
- Clinically active disease or infection in the NLF area.
- Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Exposure to any other investigational drug/device within 90 days of entering the study.
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04087395
Start Date
October 30 2019
End Date
November 9 2020
Last Update
January 24 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
California
Beverly Hills, California, United States, 90210
2
Florida
Coral Gables, Florida, United States, 33146
3
Illinois
Chicago, Illinois, United States, 60611