A Phase 2 interventional study of ELAPR002f Injectable Gel in Skin Quality Deficit, sponsored by AbbVie. Completed at 1 site in Italy. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 3 treatment sessions 1 month apart of ELAPR002f injectable gel and will be followed for 4 months.
Device: ELAPR002f Injectable Gel
Intradermal Injections
Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Live Assessment of Each Cheek Separately Using Allergan Cheek Smoothness Scale (ACSS)
The ACSS is a 5-point photonumeric scale that assesses the appearance of cheek smoothness vs coarseness where 0=none and 4=extreme. A responder is a participant with at least 1-grade improvement from baseline in ACSS.
Time frame: Up to 8 months
Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Live Assessment of Each Cheek Using Allergan Fine Line Scale (AFLS)
The AFLS is a 5-point photonumeric scale that assesses the appearance of fine lines where 0=none and 4=diffuse superficial lines. A responder is a participant with at least 1-grade improvement from baseline in AFLS.
Time frame: Up to 8 months
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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