NCT02253147

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 27, 2018

Completed
Last Updated

March 27, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

September 25, 2014

Results QC Date

November 21, 2017

Last Update Submit

February 27, 2018

Conditions

Nasolabial Folds, Wrinkles

Keywords

Nasolabial foldsDermal fillerHyaluronic acid (HA)Wrinkles

Outcome Measures

Primary Outcomes (1)

  • 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

    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®

    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®

    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)

    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)

    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

    Baseline and Weeks 24, 36, 52, 64

  • +8 more secondary outcomes

Study Arms (2)

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).

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).

Device: TEOSYAL® RHA Ultra Deep

Interventions

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.

Left side Perlane-L®, Right side TEOSYAL® RHA Ultra DeepLeft side TEOSYAL® RHA Ultra Deep, Right side Perlane-L®

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

United States

Beverly Hills, California, United States

Location

United States

Bradenton, Florida, United States

Location

United States

Chapel Hill, North Carolina, United States

Location

United States

Philadelphia, Pennsylvania, United States

Location

Results Point of Contact

Title
Clinical Project Manager
Organization
Teoxane
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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 1, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

May 1, 2016

Last Updated

March 27, 2018

Results First Posted

March 27, 2018

Record last verified: 2018-02

Locations

US(4)