TEOSYAL RHA® 1 for Neck Lines, Perioral Lines and Smiling Lines

Summary

Prospective, low-interventional, multicentric, open-labelled study to assess the performance and safety of skin beautification treatment by TEOSYAL RHA® 1 for fine lines in the neck, perioral region, and smiling lines including an exploratory arm with TEOSYAL® PureSense Redensity 1 to assess skin redensification.

Treatment phase - skin beautification:

At Visit 1 (Baseline), subjects will be injected with TEOSYAL RHA® 1 in the fine lines (Neck lines and Perioral and/or Smiling lines) depending on wrinkle severity assessed by the Principal Investigator (PI) at baseline using a specific grading scale for each indication.

The subject will be included in the study if he has been graded 2 or 3 on the Neck Lines Descriptive Scale (NLDS) at baseline.

Then:

1. The subject will be included in the perioral rhytids cohort if he has been graded 2 or 3 on the Perioral Rhytids Severity Rating Scale (PR-SRS) at baseline.
2. The subject will be included in the smiling lines cohort if he has been graded 3 or 4 on the Smiling Lines Descriptive Scale (SLDS) at baseline.

Each indication represent one cohort and all subjects will be included in the neck lines cohort.

Thus, Subject participating to the study may be treated for:

* Neck Lines and perioral Lines (2 cohorts)
* Neck Lines and Smiling Lines (2 cohorts)
* Neck Lines, Perioral Lines and Smiling Lines (3 cohorts)

An optional touch-up will be performed at Visit 2 (Month 1 +/- 1 week) if deemed necessary to achieve an optimal correction.

Exploratory phase - skin redensification:

After treatment with TEOSYAL RHA® 1, subjects will be randomized to the second phase of the study (starting at month 2 +/- 1 week): 5/6 of the subjects will enter the exploratory part of the study during which TEOSYAL® PureSense Redensity 1 (RHA1+R1 treated Group) will be assessed for skin redensification. The rest of the subjects will not receive any additional treatment for the rest of the study (RHA1 only treated group/around 11 subjects).

Note: the number of sessions treated with Redensity 1 might be adapted depending on subject treatment needs in order to achieve optimal results. This will be at PI discretion.

Subjects in the RHA+R1 treated Group will be also randomized into 2 subgroups of 28 subjects as described below:

* Sub-Group A: injection with a needle for all indications
* Sub-Group B: injection with a cannula for neck lines and smiling lines indications\* \*The perioral indication will be treated with a needle for this group.

The principal investigator (PI) will perform the study injections. He will evaluate subject aesthetic improvement using grading scales and skin quality measurements at each study visits and assess safety and tolerability of the devices during the study. Adverse events will be monitored by the Clinical Research Associate (CRA) throughout the study.

Additionally, a Blinded Evaluator will also evaluate subject aesthetic improvement using grading scales for each follow-up visits based on photographs.

Conditions

• Skin Aging
• Fine Lines of the Face and Neck

Interventions

DEVICE

TEOSYAL RHA® 1

During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will not receive any additional treatment.

DEVICE

TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (needle)

During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a needle. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5).

DEVICE

TEOSYAL RHA® 1 and TEOSYAL® PureSense Redensity 1 (cannula)

During the first phase of the study, ubjects will be treated with TEOSYAL RHA® 1 at baseline (V1) and may receive an optional treatment at 1 month (V2). In the exploratory phase of the study, subjects will receive additional treatment with TEOSYAL® PureSense Redensity 1 using a cannula. TEOSYAL® PureSense Redensity 1 will be administered over three sessions at 2, 3 and 4 months after baseline (respectively V3, V4 and V5).

Sponsors & Collaborators

• Teoxane SA

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-05

Primary Completion

2021-12-13

Completion

2022-05-31

Countries

• Spain

Study Locations