A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers

Allergan

Status: Completed

Conditions: Healthy Adults; Skin Enhancement

Treatments: Device: Juvederm® VOLITE

Study type: Interventional

Funder types: Industry

Identifiers

NCT04206293

CMO-MA-FAS-0617

Details and patient eligibility

About

To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers.

Enrollment: 11 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants
• Participants with Fitzpatrick skin type II or III
• Participant willing to receive Juvéderm® VOLITE in the forearms and agrees to complete all study required procedures, including having 6 cutaneous punch biopsies taken in the forearms and blood drawn (Human immunodeficiency virus [HIV], B and C hepatitis analysis at screening)
• Written informed consent and data privacy consent obtained

Exclusion criteria

• Pregnant or nursing woman or planning a pregnancy during the study
• Participant participating to another research on human beings or being in an exclusion period for a previous study
• Intensive exposure to sunlight or ultraviolet (UV)-rays within the previous month and foreseen during the study
• Participant having other resorbable filling product injections, a laser treatment, an ultrasound-based treatment, radiation treatment, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the studied zones within the past 12 months prior to study start
• Participant with subcutaneous retaining structure on the studied zones (meshing, threads, gold strand)
• Participant having received injections of permanent or semi-permanent filling products in the studied zones
• Participant under anti-coagulant treatment or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study
• Participant receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or Nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (herbal supplements with garlic or ginkgo biloba, etc) for 10 days prior to study treatment and 3 days after
• Participant under immunosuppressive therapy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Juvéderm® VOLITE

Experimental group

Description:

Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 centimeter (cm) x 4 cm (32 cm\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 milliliter (mL) was injected on the zone treated.

Treatment:

Device: Juvederm® VOLITE