Perioral RhytidsNCT03092219
RHA Redensity - Perioral Rhytids
A study testing TEOSYAL RHA Redensity in people with Perioral Rhytids and Aging, run by Teoxane SA at 8 sites in 2 countries.
Trial summary
Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioral Rhytids, Aging, Wrinkle
- What is being tested?
- TEOSYAL RHA Redensity
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 20 Dec 2016to 8 Jan 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient, male or female of any race, 22 years of age or older
- Moderate to severe perioral rhytids of grade 2 or 3 on the four-point PR-SRS (ranging from 0-3)
- 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.
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 susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
- Clinically significant active skin disease within 6 months
- History of connective tissue disease
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Study site
Beverly Hills, California
Study site
Coral Gables, Florida
Study site
Fairfax, Virginia
Study site
High Point, North Carolina
Study site
Omaha, Nebraska
Study site
Santa Monica, California
About this study
Official title: A Randomized, Blinded, No-Treatment Control, Multicenter, Prospective Clinical Study of TEOSYAL RHA® Redensity for the Treatment of Moderate to Severe Dynamic Perioral Rhytids
Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment).
The Treating Investigator (TI) at screening will evaluate the subject's perioral rhytids severity using the Perioral Rhytids Severity Rating Scale (PR-SRS) for eligibility of the subject for the study.
Read more
The Blinded Live Evaluator (BLE) at screening will evaluate the subject's perioral rhytids severity using the PR-SRS in order to confirm eligibility and to establish a pre-treatment (Baseline) score for assessment of effectiveness.
This is done independently of the TI, and exact concordance between the BLE and the TI is not necessary for eligibility of the subject in this study.
Enrolled subjects will be randomized to either the TEOSYAL RHA® Redensity treatment group or the "No-Treatment" control group (ratio 3:1).
The TI will administrate the study device, and if necessary, subjects will receive a touch-up treatment 14 days following the initial treatment to optimize the results.
The TI will conduct safety and effectiveness evaluations at study visits, which occurred at Week 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
The Blinded Live Evaluator (BLE) will conduct assessments of effectiveness during the trial, including assessment of the primary endpoint at Week 8 after the last treatment (i.e., initial or touch-up treatment). The BLE will conduct effectiveness evaluations at Week 8, 12, 16, 24, 36, and 52 after the last treatment (i.e., initial or touch-up treatment).
All subjects will be followed for 52 weeks after the last treatment (i.e., initial treatment or touch-up), at which point they will be offered Repeat-Treatment (provided that the TI deems the treatment to be appropriate and the subject agrees) and will be then followed for 4 weeks after Repeat-Treatment before exiting the study.
If a subject returns to his pre-treatment PR-SRS score at Week 12 or Week 16 or Week 24 or Week 36 after initial treatment or touch up (as assessed by the TI), subjects are eligible for optional Early-Retreatment if necessary at 12 or 16 or 24 or 36 weeks after last treatment (provided that the TI deems the treatment appropriate, and the subject agrees).
Subjects will be then followed for an additional 4 weeks after Repeat-Treatment.
Subjects who will receive optional Early-Retreatment at Week 12 or Week 16 or Week 24 or Week 36 after the after initial treatment or touch-up, will be offered Repeat-Treatment at Week 52.
Subjects randomized to the "No-Treatment" control group will receive their first treatment after the primary endpoint evaluation (Week 8 after randomization) and then will be followed the same schedule as the initial treatment group.
- Conditions
- Perioral Rhytids, Aging, Wrinkle
- Being tested
- TEOSYAL RHA Redensity
- Keywords
- Perioral rhytids, Dermal filler, Hyaluronic acid, Aging, Wrinkle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEOSYAL RHA RedensityDevice
A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
| Study group | Role | What they receive |
|---|---|---|
| TEOSYAL RHA Redensity | Experimental | Injection of TEOSYAL RHA Redensity into the perioral lines (n=150). Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks. Receives: Device: TEOSYAL RHA Redensity |
| No Treatment | No intervention | No treatment control group (n=52). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe).
Change = (Week 8 - Baseline score).
A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this primary outcome measure.
Measured: Week 8 after last treatment
Secondary outcomes (10)
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').
To calculate the FACE-Q score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior outcome and adapted to a 100- unit scale.
The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Measured: Baseline, Weeks 4 and 8 after last treatment
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement.
Possible scores range from "much improved", "improved", "no change", "worse", to "much worse".
The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Measured: Weeks 4 and 8 after last treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement.
Possible scores range from "much improved", "improved", "no change", "worse", to "much worse".
The GAI will be assessed using the pre-injection baseline photograph.
The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Measured: Week 8 after last treatment
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment.
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).
The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Measured: Week 8 after last treatment
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity.
The Treating Investigator will assess adverse events and record details of seriousness, severity, duration, and action taken with the study device, and relationship to the study device. AEs will be reported from the time of consent until week 52 or to 1 month following the last treatment.
Measured: Baseline through Week 52 following the last treatment and 4 weeks following re-treatment
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity.
The subjects will receive 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 treatment. The diary will be discussed during telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).
The subject diary captures 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 includes 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 and touch-up (2 weeks)
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity.
The Injection Site Pain (during injection and post-injection) will be self-assessed by the subject using a 100 mm Visual Analog Scale (VAS).
VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain.
Measured: Baseline, Weeks 2, 12, 16, 24, 36 and 52
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment.
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment.
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. Lip sensation
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start20 Dec 2016
- Primary completion17 Dec 2017
- Study completion8 Jan 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioral RhytidsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teoxane SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092219
- Sponsor's protocol ID
- TEO-RHA-1501
- Status last verified
- Jun 2023
- First submitted
- 21 Mar 2017
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Sundaram H, Shamban A, Schlessinger J, Kaufman-Janette J, Joseph JH, Lupin M, Draelos Z, Carey W, Smith S, Eaton L. Efficacy and Safety of a New Resilient Hyaluronic Acid Filler in the Correction of Moderate-to-Severe Dynamic Perioral Rhytides: A 52-Week Prospective, Multicenter, Controlled, Randomized, Evaluator-Blinded Study. Dermatol Surg. 2022 Jan 1;48(1):87-93. doi: 10.1097/DSS.0000000000003238.
PubMed 34608092
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, No-Treatment Control, Multicenter, Prospective Clinical Study of TEOSYAL RHA® Redensity for the Treatment of Moderate to Severe Dynamic Perioral Rhytids
- ClinicalTrials.gov ID
- NCT03092219
- Acronym / sponsor ID
- TEO-RHA-1501
- Conditions
- Perioral Rhytids, Aging, Wrinkle
- Keywords
- Perioral rhytids, Dermal filler, Hyaluronic acid, Aging, Wrinkle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Posted 8 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment).
The Treating Investigator (TI) at screening will evaluate the subject's perioral rhytids severity using the Perioral Rhytids Severity Rating Scale (PR-SRS) for eligibility of the subject for the study.
The Blinded Live Evaluator (BLE) at screening will evaluate the subject's perioral rhytids severity using the PR-SRS in order to confirm eligibility and to establish a pre-treatment (Baseline) score for assessment of effectiveness.
This is done independently of the TI, and exact concordance between the BLE and the TI is not necessary for eligibility of the subject in this study.
Enrolled subjects will be randomized to either the TEOSYAL RHA® Redensity treatment group or the "No-Treatment" control group (ratio 3:1).
The TI will administrate the study device, and if necessary, subjects will receive a touch-up treatment 14 days following the initial treatment to optimize the results.
The TI will conduct safety and effectiveness evaluations at study visits, which occurred at Week 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
The Blinded Live Evaluator (BLE) will conduct assessments of effectiveness during the trial, including assessment of the primary endpoint at Week 8 after the last treatment (i.e., initial or touch-up treatment). The BLE will conduct effectiveness evaluations at Week 8, 12, 16, 24, 36, and 52 after the last treatment (i.e., initial or touch-up treatment).
All subjects will be followed for 52 weeks after the last treatment (i.e., initial treatment or touch-up), at which point they will be offered Repeat-Treatment (provided that the TI deems the treatment to be appropriate and the subject agrees) and will be then followed for 4 weeks after Repeat-Treatment before exiting the study.
If a subject returns to his pre-treatment PR-SRS score at Week 12 or Week 16 or Week 24 or Week 36 after initial treatment or touch up (as assessed by the TI), subjects are eligible for optional Early-Retreatment if necessary at 12 or 16 or 24 or 36 weeks after last treatment (provided that the TI deems the treatment appropriate, and the subject agrees).
Subjects will be then followed for an additional 4 weeks after Repeat-Treatment.
Subjects who will receive optional Early-Retreatment at Week 12 or Week 16 or Week 24 or Week 36 after the after initial treatment or touch-up, will be offered Repeat-Treatment at Week 52.
Subjects randomized to the "No-Treatment" control group will receive their first treatment after the primary endpoint evaluation (Week 8 after randomization) and then will be followed the same schedule as the initial treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEOSYAL RHA Redensity | Experimental | Device: TEOSYAL RHA RedensityInjection of TEOSYAL RHA Redensity into the perioral lines (n=150). Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks. |
| No Treatment | No intervention | –No treatment control group (n=52). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatient, male or female of any race, 22 years of age or older
- Moderate to severe perioral rhytids of grade 2 or 3 on the four-point PR-SRS (ranging from 0-3)
- 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.
Key exclusion criteria (5 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 susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
- Clinically significant active skin disease within 6 months
- History of connective tissue disease
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 RedensityA sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. | Device | TEOSYAL RHA Redensity |
Primary outcome
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
Time frame: Week 8 after last treatment
The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this primary outcome measure.
10 secondary outcomes
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment.
Time frame: Baseline, Weeks 4 and 8 after last treatment
Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment.
Time frame: Weeks 4 and 8 after last treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
Time frame: Week 8 after last treatment
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment.
Time frame: Week 8 after last treatment
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity.
Time frame: Baseline through Week 52 following the last treatment and 4 weeks following re-treatment
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity.
Time frame: During 14 days after initial treatment and touch-up (2 weeks)
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity.
Time frame: Baseline, Weeks 2, 12, 16, 24, 36 and 52
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34608092Sundaram H, Shamban A, Schlessinger J, Kaufman-Janette J, Joseph JH, Lupin M, Draelos Z, Carey W, Smith S, Eaton L. Efficacy and Safety of a New Resilient Hyaluronic Acid Filler in the Correction of Moderate-to-Severe Dynamic Perioral Rhytides: A 52-Week Prospective, Multicenter, Controlled, Randomized, Evaluator-Blinded Study. Dermatol Surg. 2022 Jan 1;48(1):87-93. doi: 10.1097/DSS.0000000000003238.
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEOSYAL RHA Redensity in people with Perioral Rhytids and Aging, run by Teoxane SA at 8 sites in 2 countries.
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 5 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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 8 Jul 2020). 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?
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. (time frame: Week 8 after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092219, which also lists 1 linked publication.
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 22 Jun 2023.