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
Outpatient, male or female of any race, 22 years of age or older
Lip fullness of grade 1 to 3 on the TLFS (ranging from 1 to 5) who desire at least 1 point of correction for upper and/or lower lips OR has Fitzpatrick skin type V or VI and has lip fullness grade 4 or 5 on the TLFS who desire treatment to the vermillion body for upper and/or lower lips. The BLE and TI must independently assess and agree that this criterion is met; however, concordance of fullness is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the assessments differ by 2 points or more on the scale, the subject will not be eligible.
Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
Able to follow study instructions and complete all required visits.
Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed.
You may not be if
Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control
Known hypersensitivity/allergy to any component of the study devices
Clinically significant active skin disease within 6 months
Has a history of or currently has an auto-immune disease.
