RHA Redensity - Perioral Rhytids

NCT03092219 | Completed Results FDA Device

• 1 other identifier: TEO-RHA-1501
• Study Type: interventional
• Target: 202
• Locations: 2 countries
• Sites: 8

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.

Conditions

Perioral Rhytids; Aging; Wrinkle

Keywords

Perioral rhytids; Dermal filler; Hyaluronic acid; Aging; Wrinkle

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  Week 8 after last treatment

• Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity.

  Baseline through Week 52 following the last treatment and 4 weeks following re-treatment

Other Outcomes (15)

• 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.

  Weeks 4 and 8 after last treatment

• 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.

  Weeks 4 and 8 after last treatment

• Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.

  Week 8 after last treatment

Study Arms (2)

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.

Device: TEOSYAL RHA Redensity

No Treatment

NO INTERVENTION

No treatment control group (n=52).

Interventions

TEOSYAL RHA Redensity DEVICE

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.

TEOSYAL RHA Redensity

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teoxane SA: lead

Study Sites (8)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Coral Gables, Florida, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Montreal, Canada

Location

Unknown Facility

Victoria, Canada

Location

Related Publications (1)

• 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.

  PMID: 34608092 DERIVED

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Teoxane SA

m.chenet@teoxane.com

+41(0) 22 344 96 36

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: December 20, 2016
• Primary Completion: December 17, 2017
• Study Completion: January 8, 2019
• Last Updated: June 22, 2023
• Results First Posted: July 8, 2020

Record last verified: 2023-06

Locations

CA (2); US (6)