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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2025-02-24

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.

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Detailed Description

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Conditions

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Skin Quality Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ELAPR002f Injectable Gel

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

Group Type EXPERIMENTAL

ELAPR002f Injectable Gel

Intervention Type DEVICE

Intradermal Injections

Interventions

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ELAPR002f Injectable Gel

Intradermal Injections

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No