Restylane Defyne in a Stepwise Treatment Approach

Galderma

Status: Completed

Conditions: Lower Face Folds and Lines

Treatments: Device: Restylane Defyne

Study type: Interventional

Funder types: Industry

Identifiers

NCT04520997

05DF1910

Details and patient eligibility

About

This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.

Enrollment: 62 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects willed to comply with the requirements of the study and provided a signed written informed consent
• Subjects willed to undergo augmentation and correction therapy in the studied indications
• Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21

Exclusion criteria

• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
• Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
• Participation in any interventional clinical study within 30 days of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Down-up

Experimental group

Description:

Participants in this group received up to 2 mL Restylane Defyne on chin at baseline and up to 2 mL of Restylane Defyne per NLF at baseline and up to 2 mL per ML of Restylane Defyne at Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator.

Treatment:

Device: Restylane Defyne

Device: Restylane Defyne

Top-down

Experimental group

Description:

Participants in this group received up to 2 mL Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at baseline and up to 2mL on chin Week 3. An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator.

Treatment:

Device: Restylane Defyne

Device: Restylane Defyne