Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers (FRESH)

Galderma

Status: Completed

Conditions: Facial Wrinkles

Treatments: Device: hyaluronic acid dermal fillers

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151436

RD.03.CIP.29089

2009-018163-28 (EudraCT Number)

Details and patient eligibility

About

The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

Full description

The range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: Emervel Touch, Emervel Classic, Emervel Deep, Emervel Volume and Emervel Lips.

The study will last 6 month.

Injections will be performed at baseline. If necessary, the investigator will perform touch-up injections at the following visit (3 weeks later).

Investigator and subject satisfaction will be collected through questionnaires.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Seeking tissue augmentation treatment on the face,
• Presenting a score of 3 (Moderately deep wrinkle)or 4 (Deep wrinkle) on the Lemperle Rating Scale (LRS) of both nasolabial folds.

Exclusion criteria

• At risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices,
• Who underwent previous injection of permanent filler in the injected area.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

hyaluronic acid

Experimental group

Treatment:

Device: hyaluronic acid dermal fillers