Clinical trial NCT03092219: RHA Redensity - Perioral Rhytids
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioral Rhytids
Aging
Wrinkle
Keywords: Perioral rhytids
Dermal filler
Hyaluronic acid
Aging
Wrinkle
Lead sponsor: Teoxane SA
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 202
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.


Eligibility criteria: Inclusion Criteria :

* 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.

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 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

Primary outcomes:
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.
timeFrame: Week 8 after last treatment
Secondary outcomes:
measure: 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.
timeFrame: Baseline, Weeks 4 and 8 after last treatment
measure: 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.
timeFrame: Weeks 4 and 8 after last treatment
measure: 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.
timeFrame: Week 8 after last treatment
measure: Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment.
timeFrame: Week 8 after last treatment
measure: Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity.
timeFrame: Baseline through Week 52 following the last treatment and 4 weeks following re-treatment
measure: Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity.
timeFrame: During 14 days after initial treatment and touch-up (2 weeks)
measure: Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity.
timeFrame: Baseline, Weeks 2, 12, 16, 24, 36 and 52
measure: Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
timeFrame: 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.
measure: Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
timeFrame: 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.
measure: Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
timeFrame: 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.
Other outcomes:
measure: Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment.
timeFrame: Weeks 4 and 8 after last treatment
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment.
timeFrame: Weeks 4 and 8 after last treatment
measure: Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
timeFrame: Week 8 after last treatment
measure: Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment.
timeFrame: Weeks 4 and 8 after last treatment
measure: Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment.
timeFrame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
measure: Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment.
timeFrame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
measure: Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment.
timeFrame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
measure: Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment.
timeFrame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
measure: Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment.
timeFrame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
measure: Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment.
timeFrame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
measure: Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment.
timeFrame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment.
timeFrame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment.
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment.
timeFrame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
measure: Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment.
timeFrame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
measure: Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment.
timeFrame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
Locations:
city: Beverly Hills
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Omaha
country: United States
state: Nebraska
city: High Point
country: United States
state: North Carolina
city: Fairfax
country: United States
state: Virginia
city: Montreal
country: Canada
city: Victoria
country: Canada
Study officials:
References:
citation: 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.