Nasolabial Folds, WrinklesNCT02253147
TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds
A study testing TEOSYAL® RHA Ultra Deep in people with Nasolabial Folds, Wrinkles, run by Teoxane SA at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Nasolabial Folds, Wrinkles
- What is being tested?
- TEOSYAL® RHA Ultra Deep
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
United States
Beverly Hills, California
United States
Bradenton, Florida
United States
Chapel Hill, North Carolina
United States
Philadelphia, Pennsylvania
About this study
Official title: A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA (Resilient Hyaluronic Acid) Ultra Deep Versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial Folds
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.
- Conditions
- Nasolabial Folds, Wrinkles
- Being tested
- TEOSYAL® RHA Ultra Deep
- Keywords
- Nasolabial folds, Dermal filler, Hyaluronic acid (HA), Wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEOSYAL® RHA Ultra DeepDevice
A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27Gauge ½" disposable sterile needles.
| Study group | Role | What they receive |
|---|---|---|
| Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L® | Experimental | Split-face injection of TEOSYAL® RHA Ultra Deep into the left Naso Labial Folds (NLFs) and Perlane-L® into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). Receives: Device: TEOSYAL® RHA Ultra Deep |
| Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep | Experimental | Split-face injection of Perlane-L® into the left Naso Labial Folds (NLFs) and TEOSYAL® RHA Ultra Deep into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). Receives: Device: TEOSYAL® RHA Ultra Deep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
BLE =Blinded Live Evaluator
Measured: Baseline and 24 weeks after last treatment
Secondary outcomes (13)
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).
The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other".
The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed.
The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)
Measured: During 14 days after initial treatment (D0) and touch-up (2 weeks)
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
Measured: During Injection and 5, 15, 30 minutes post-injection
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)
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
Measured: Baseline and Weeks 24, 36, 52, 64
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)
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
Measured: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
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
A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline
Measured: Baseline and Weeks 24, 36, 52, 64
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
A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline
Measured: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
GAI was assessed using the baseline photograph. Each side of the face was assessed independently.
Measured: Weeks 24, 36, 52, 64
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
GAI was assessed using the baseline photograph. Subjects will be instructed: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale".
Each side of the face was assessed independently.
Measured: Weeks 4, 12, 24, 36, 52, 64
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').
The subject was instructed as follows: "These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:", and provided response.
- How deep your nasolabial fold are?
- How your nasolabial folds look when your face is relaxed (still)?
- How old your nasolabial folds make you look?
- How your nasolabial folds look when you smile?
- How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome.
Measured: Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64
Subject's Satisfaction Score
Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'
Measured: Weeks 2, 4, 12, 24, 36, 52, 64
Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
Measured: Week 2
Number of Subjects Receiving Touch-up Treatment
Measured: Week 2
Number of Subjects Receiving Re-treatment
Measured: Weeks 24, 36, 52, 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasolabial Folds, WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teoxane SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253147
- Sponsor's protocol ID
- TEO-RHA-1402
- Status last verified
- Feb 2018
- First submitted
- 25 Sep 2014
- Last updated
- 27 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA (Resilient Hyaluronic Acid) Ultra Deep Versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02253147
- Acronym / sponsor ID
- TEO-RHA-1402
- Conditions
- Nasolabial Folds, Wrinkles
- Keywords
- Nasolabial folds, Dermal filler, Hyaluronic acid (HA), Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 27 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L® | Experimental | Device: TEOSYAL® RHA Ultra DeepSplit-face injection of TEOSYAL® RHA Ultra Deep into the left Naso Labial Folds (NLFs) and Perlane-L® into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). |
| Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep | Experimental | Device: TEOSYAL® RHA Ultra DeepSplit-face injection of Perlane-L® into the left Naso Labial Folds (NLFs) and TEOSYAL® RHA Ultra Deep into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEOSYAL® RHA Ultra DeepA sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27Gauge ½" disposable sterile needles. | Device | Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep, Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L® |
Primary outcome
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.
Time frame: Baseline and 24 weeks after last treatment
WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'. BLE =Blinded Live Evaluator
13 secondary outcomes
Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Time frame: During 14 days after initial treatment (D0) and touch-up (2 weeks)
Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
Time frame: During Injection and 5, 15, 30 minutes post-injection
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)
Time frame: Baseline and Weeks 24, 36, 52, 64
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)
Time frame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
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
Time frame: Baseline and Weeks 24, 36, 52, 64
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
Time frame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
Time frame: Weeks 24, 36, 52, 64
Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
Time frame: Weeks 4, 12, 24, 36, 52, 64
Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
Time frame: Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64
Subject's Satisfaction Score
Time frame: Weeks 2, 4, 12, 24, 36, 52, 64
Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
Time frame: Week 2
Number of Subjects Receiving Touch-up Treatment
Time frame: Week 2
Number of Subjects Receiving Re-treatment
Time frame: Weeks 24, 36, 52, 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEOSYAL® RHA Ultra Deep in people with Nasolabial Folds, Wrinkles, run by Teoxane SA at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline and 24 weeks after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.