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

March 4, 2025 updated by: AbbVie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37134
        • CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 226370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ELAPR002f Injectable Gel
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

What is the study measuring?

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)
Time Frame: 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.
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)
Time Frame: 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.
Up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Actual)

February 24, 2025

Study Completion (Actual)

February 24, 2025

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2028-601-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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