Status:
COMPLETED
TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds
Lead Sponsor:
Teoxane SA
Collaborating Sponsors:
ethica Clinical Research Inc.
Conditions:
Nasolabial Folds, Wrinkles
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a controlled, randomi...
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 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 form.
Exclusion
- 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;
- 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, ASA, 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).
- Evidence of 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT02253147
Start Date
September 1 2014
End Date
May 1 2016
Last Update
March 27 2018
Active Locations (4)
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1
United States
Beverly Hills, California, United States
2
United States
Bradenton, Florida, United States
3
United States
Chapel Hill, North Carolina, United States
4
United States
Philadelphia, Pennsylvania, United States