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

Phase 2

Active, not recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Participants in general good health, in the opinion of the investigator, with no known 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.

Arm && Interventions

Group	Intervention	Description
ELAPR002f Injectable Gel	ELAPR002f Injectable Gel	Participants will receive 3 treatment sessions 1 month apart of ELAPR002f injectable gel and will be followed for 4 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Live Assessment of Each Cheek Separately Using Allergan Cheek Smoothness Scale (ACSS)	Up to 8 months	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.
Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Live Assessment of Each Cheek Using Allergan Fine Line Scale (AFLS)	Up to 8 months	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 226370
🇮🇹
Verona, Italy

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