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An Open-label Study Evaluating the Safety and Effectiveness of Intradermal Injections of ELAPR002f Injectable Gel in the Improvement of Multiple Attributes of Skin Quality in Healthy Adults
Elastin is a protein found in the dermis of the skin that is gradually lost with aging which impacts skin tissue and leads to reduced structural integrity, hydration, and elasticity of the skin, resulting in loose skin and the formation of folds and wrinkles. Loose skin, folds, and wrinkles can be treated by injecting biocompatible structures to fill the the affected area and improve elasticity/hydration upon implantation. The purpose of this study is to evaluate the safety and effectiveness of ELAPR002f injectable gel in adult participants for the improvement of skin quality in adults. ELAPR002f injectable gel is an investigational device being developed for the improvement of facial skin quality attributes such as fine lines, elasticity, and hydration. Approximately 30 participants 30 to 60 years of age seeking improvement of skin quality will be enrolled. Participants will receive 3 treatment sessions, 1 month apart, of ELAPR002f injectable gel to each cheek and behind 1 ear (for histological assessment) and will be followed up for up to 4 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Age
30 - 60 years
Sex
ALL
Healthy Volunteers
No
CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 226370
Verona, Italy
Start Date
December 19, 2023
Primary Completion Date
February 24, 2025
Completion Date
February 24, 2025
Last Updated
March 5, 2025
30
ACTUAL participants
ELAPR002f Injectable Gel
DEVICE
Lead Sponsor
AbbVie
Data Source & Attribution
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