Restylane Defyne in a Stepwise Treatment Approach

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2021-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Lower Face Folds and Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Down-up

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.

Group Type EXPERIMENTAL

Restylane Defyne

Intervention Type DEVICE

Up to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.

Top-down

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.

Group Type EXPERIMENTAL

Restylane Defyne

Intervention Type DEVICE

Up to 2 ml of Restylane Defyne per NLF and ML at baseline, up to 2 ml of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at week 3 and optional touch-up of up to 2 ml per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.

Interventions

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Restylane Defyne

Up to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.

Intervention Type DEVICE

Restylane Defyne

Up to 2 ml of Restylane Defyne per NLF and ML at baseline, up to 2 ml of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at week 3 and optional touch-up of up to 2 ml per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No