N/A
N=118
TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds
Nasolabial Folds, Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT02253147 ↗Enrolled (actual)
118
Serious AEs
2.5%
Results posted
Mar 2018
Primary outcome: Primary: Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE. — -1.34; -1.16 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TEOSYAL® RHA Ultra Deep (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Teoxane SA
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE. |
-1.34; -1.16 | — |
| SECONDARY Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L® |
70; 72; 17; 22; 50; 56 | — |
| SECONDARY Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L® |
23.43; 23.85; 6.22; 5.33; 2.67; 2.82 | — |
| SECONDARY Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE) |
-1.34; -1.16; -1.28; -1.12; -1.23; -1.05 | — |
| SECONDARY Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI) |
-1.77; -1.51; -1.85; -1.60; -1.70; -1.34 | — |
| SECONDARY Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE |
97.7; 88.6; 90.7; 87.2; 87.0; 83.1 | — |
| SECONDARY Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI |
97.7; 93.2; 100.0; 97.7; 95.5; 88.6 | — |
| SECONDARY Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE) |
84; 80; 80; 77; 65; 62 | — |
| SECONDARY Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale. |
87; 88; 87; 85; 82; 78 | — |
| SECONDARY Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire |
24.7; 25.7; 77.1; 74.0; 84.3; 81.2 | — |
| SECONDARY Subject's Satisfaction Score |
1.49; 1.63; 1.28; 1.31; 1.41; 1.62 | — |
| SECONDARY Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up) |
1.79; 1.75 | — |
| SECONDARY Number of Subjects Receiving Touch-up Treatment |
28; 38 | — |
| SECONDARY Number of Subjects Receiving Re-treatment |
6; 6; 3; 6; 12; 13 | — |
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, randomized, double-blinded, within subject (split-face), multicenter, prospective clinical study.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02253147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.