Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teoxane SA
With
ethica Clinical Research Inc.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Outpatient, male or female of any race, 22 years of age or older; female subjects of childbearing potential must have a negative urine pregnancy test and practice a reliable method of contraception
NLFs classified as WSRS grade 3 or 4 (same score for each side)
Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
Able to follow study instructions and likely to complete all required visits;
Signed informed consent and HIPAA (Health Insurance Portability and Accountability Act) form
You may not be if
Female subjects that are pregnant or breast-feeding, or of childbearing potential and not practicing reliable birth control
Known hypersensitivity/allergy to any component of the study devices
Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, history of anaphylactic shock
Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
Clinically significant active skin disease within 6 months
History of active chronic debilitating systemic disease
History of connective tissue disease
History of malignancy (excl. non-melanoma skin cancer) within past 5 years
History of bleeding disorders
Need for clinically significant and continuous medical treatment within 2 weeks prior to first visit
Received/used a prohibited treatment/procedure within certain time periods (e.g., bioresorbable fillers, NSAIDS, acetylsalicylic acid, high dose vitamin E, corticosteroids, interferon, anti-coagulation therapies, laser/light therapies, botulinum toxin injections (frontalis and glabella complex treatment permitted), prescription strength topical retinoids, facial peels, excisional facial surgery, clinically significant oral or maxillofacial surgery)
Clinically significant alcohol or drug abuse, or history of poor cooperation, non-compliance with medical treatment, or unreliability
Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such as excessive facial hair, traumatic or surgical facial scars, and/or excessive hyperpigmentation in the treatment areas
A condition or situation that may put the subject at significant risk, confound the study results, or significantly interfere with the subject participation
