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 (ARTIST)

Galderma

Status: Completed

Conditions: Chin Augmentation

Treatments: Device: Restylane Defyne; Device: Restylane Shaype; Device: Restylane Lyft lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06428214

05DF2307

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Restylane Shaype

Experimental group

Description:

Participants will receive Restylane Shaype in the chin area only.

Treatment:

Device: Restylane Shaype

Restylane Shaype with Restylane Defyne

Other group

Description:

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

Treatment:

Device: Restylane Shaype

Device: Restylane Defyne

Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine

Other group

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.

Treatment:

Device: Restylane Lyft lidocaine

Device: Restylane Shaype

Device: Restylane Defyne