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

NCT06151535 | Completed Phase 2

• 1 other identifier: 2028-601-008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Quality Deficit

Keywords

Skin Quality Deficit; ELAPR002f Injectable Gel

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

ELAPR002f Injectable Gel

EXPERIMENTAL

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

Device: ELAPR002f Injectable Gel

Interventions

ELAPR002f Injectable Gel DEVICE

Intradermal Injections

ELAPR002f Injectable Gel

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 226370

Verona, 37134, Italy

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: November 30, 2023
• Study Start: December 19, 2023
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IT (1)