## Protocol Section
### Identification Module
**NCT ID:** NCT06428214

**Acronym:** ARTIST

**Brief Title:** A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies

**Official Title:** A Post-market, Open-label, 3-Armed, Parallel Group, Multicenter Study to Evaluate Aesthetic Improvement and Safety of Restylane Shaype for Temporary Augmentation of the Chin Region Alone or in Combination With Restylane Defyne and Restylane Lyft Lidocaine Treatment in the Lower Face and Midface

#### Organization Study ID Info
**ID:** 05DF2307
#### Organization
**Class:** INDUSTRY
**Full Name:** Galderma R&D
### Status Module
#### Completion Date
**Date:** 2024-09-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Galderma R&D

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator.

### Conditions Module

**Conditions:**

- Chin Augmentation

**Keywords:**

- lower face

- Mid face

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 45

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive Restylane Shaype in the chin area only.

**Intervention Names:**

- Device: Restylane Shaype

**Label:** Restylane Shaype

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin.

**Intervention Names:**

- Device: Restylane Shaype

- Device: Restylane Defyne

**Label:** Restylane Shaype with Restylane Defyne

**Type:** OTHER

#### Arm Group 3

**Description:** Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Participants in this group will be treated with Restylane Lyft lidocaine in the midface, nasolabial folds (NLF) and /or jawline.

**Intervention Names:**

- Device: Restylane Shaype

- Device: Restylane Defyne

- Device: Restylane Lyft lidocaine

**Label:** Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Restylane Shaype

- Restylane Shaype with Restylane Defyne

- Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine

**Description:** Injection

**Name:** Restylane Shaype

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Restylane Shaype with Restylane Defyne

- Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine

**Description:** Injection

**Name:** Restylane Defyne

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine

**Description:** Injection

**Name:** Restylane Lyft lidocaine

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8

**Time Frame:** At week 8

#### Secondary Outcomes

**Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4

**Time Frame:** At week 4

**Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8

**Time Frame:** At weeks 4 and 8

**Measure:** Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8

**Time Frame:** At week 8

**Measure:** Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8

**Time Frame:** At week 8

**Measure:** Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8

**Time Frame:** At week 8

**Measure:** Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8

**Time Frame:** At week 8

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, over the age of 18.
* Intent to receive treatment for temporary augmentation in the chin region.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics
* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
* Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim.
* Any previous aesthetic procedures or implants.
* Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation.
* Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline.
* Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinical.studies@galderma.com

**Name:** Galderma Research & Development

**Phone:** 1-866-735-4137

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Vancouver

**Country:** Canada

**Facility:** Galderma Investigational Site # 8754

**State:** British Columbia

**Status:** RECRUITING

**Zip:** V6H 4E1

**Location 2:**

**City:** Burlington

**Country:** Canada

**Facility:** Galderma Investigational Site 8379

**State:** Ontario

**Status:** RECRUITING

**Zip:** L7N3N2

**Location 3:**

**City:** Westmount

**Country:** Canada

**Facility:** Galderma Investigational Site 8690

**State:** Quebec

**Status:** RECRUITING

**Zip:** H3Z 1C3

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000061567

- Term: Voltage-Gated Sodium Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000055675

- Term: Viscosupplements

- ID: D000020011

- Term: Protective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: HIGH

- As Found: Bromide

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M28295

- Name: Viscosupplements

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008012

- Term: Lidocaine

- ID: D000006820

- Term: Hyaluronic Acid

### Misc Info Module

- Version Holder: 2024-05-31
