Clinical trial NCT04069585: RHA® Redensity With New Anesthetic Agent - Perioral Rhytids
Official title: A Randomized, Controlled, Double-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Compare the Level of Pain Using the Dermal Filler RHA® Redensity Formulated With Two Different Anesthetics in the Treatment of Perioral Rhytids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Pain
Keywords: Hyaluronic Acid
Perioral rhytids
Anesthetic
Lidocaine
Lead sponsor: Teoxane SA
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-face design
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.

At screening, the Treating Investigator (TI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.

At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the TI injecting study devices were blinded.

Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant.

Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.

Subjects attended Visit 2 (30 days post-injection) where efficacy and safety assessments were conducted.

Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2.

If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.


Eligibility criteria: Inclusion Criteria:

1. Outpatient, male or female of any race, 22 years of age or older. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
2. Moderate to severe bilateral perioral rhytids (grade 2 or 3 on PR-SRS).
3. Perioral rhytids of the same PR-SRS grade on the left and right sides of the mouth.
4. Able to follow study instructions and complete all required visits.
5. Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.

Exclusion Criteria:

1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
2. Known hypersensitivity or previous allergic reaction to any component of the study devices.
3. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
4. Clinically significant active skin disease or infection in the perioral area within 6 months prior to study entry (TI discretion).
5. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
6. Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
7. History or presence of condition or feature that may confound the interpretation of the results in the perioral region, for example, tattoo, significant facial hair, acne scaring, prior surgery in the area, potential for active disease or infection flare up such as herpes simplex.
8. History of skin cancer in the treatment area.
9. Elective, clinically significant facial procedures that may confound the interpretation of the results in the perioral region (TI discretion), prior to study enrollment.
10. Clinically active disease or infection in the perioral area or mouth (e.g., dental abscess).

12. Exposure to any other investigational drug/device within 90 days of entering the study.

13. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.

Primary outcomes:
measure: Non-inferiority of RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Terms of Reducing Pain During Device Injection Into the Upper Perioral Rhytids.
timeFrame: Visit 1 - During Injection
Secondary outcomes:
measure: Difference Between RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine in Term of Reducing Pain at 15, 30, 45 and 60 Minutes Post-injection in Each Side of the Mouth.
timeFrame: Visit 1 - 15, 30, 45 and 60 minutes post-injection
measure: Change From Baseline of PR-SRS Score for RHA® Redensity With New Anesthetic Agent Vs RHA® Redensity With Lidocaine for the Correction of Perioral Rhytids as Assessed by the Treating Investigator (TI)
timeFrame: Visit 1 (Baseline, pre-injection) - Visit 1 (post-injection), Visit 2 (Day 30)
measure: Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade on the Perioral Rhytids Severity Rating Scale (PR-SRS) Compared to Baseline, as Assessed by the TI
timeFrame: Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)
measure: Subject's Perception of Treatment Effectiveness as Per the FACE-Q (Perioral Rhytids Domain) Questionnaire.
timeFrame: Visit 1 (Baseline) and Visit 2 (Day 30)
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Treating Investigator (TI)
timeFrame: Visit 1 (post-injection) and Visit 2 (Day 30)
measure: Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale According to Subject's Self-assessment
timeFrame: Visit 1 (post-injection) and Visit 2 (Day 30)
measure: Number of Both "Satisfied" or "Very Satisfied" Subjects With Study Treatment Using the Subject's Satisfaction Scale
timeFrame: Visit 1 (post-injection) and Visit 2 (Day 30)
measure: Number of Subjects With Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of RHA® Redensity With New Anesthetic Agent Versus RHA® Redensity With Lidocaine
timeFrame: During 30 days after injection
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: California
state: California
city: Coral Gables
country: United States
facility: Florida
state: Florida
city: Chicago
country: United States
facility: Chicago
state: Illinois
Study officials:
References:
citation: Kaufman-Janette J, Joseph JH, Dayan SH, Smith S, Eaton L, Maffert P. Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics. Dermatol Surg. 2022 Oct 1;48(10):1065-1070. doi: 10.1097/DSS.0000000000003541. Epub 2022 Jul 13.