Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04206293
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT04206293
Study Brief:
Protocol Section:
NCT04206293