A Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel for the Improvement of Skin Quality in Adult Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Skin Quality Deficit

Intervention / Treatment
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* Device: ELAPR002f Injectable Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in general good health as determined by medical evaluation, with no active COVID-19 infection, seeking improvement of facial skin quality. Moderate or severe (symmetric grade 2 or 3 on the Allergan Fine Lines Scale [AFLS] and Allergan Cheek Smoothness Scale [ACSS]) fine lines and cheek smoothness scores on both cheeks based on investigator's live assessment. Each cheek is amenable to at least a 1 point improvement on the AFLS and ACSS. Exclusion Criteria: Current cutaneous or mucosal inflammatory or infectious processes (eg, herpes), rosacea, abscess, an unhealed wound, active acne, or a cancerous or precancerous lesion, on the face or behind the ears. History of pigmentation disorders or current pigmentation disorder on the face or behind the ears. Active smoker. Currently using topical retinoids, or have used topical retinoids in the past 60 days (2 months) on the face or behind the ears.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELAPR002f Injectable Gel<br>Participants will receive 3 treatment sessions 1 month apart of ELAPR002f injectable gel and will be followed for 4 months. | Device: ELAPR002f Injectable Gel<br>* Intradermal Injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Quality Deficit, ELAPR002f Injectable Gel