A Multicenter, Cohort-design, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ELAPR002f injectable gel is an investigational device being developed for the treatment of facial atrophic acne scars. There are 2 cohorts in this study. In Cohort 1, all participants will receive ELAPR002f injectable gel. In Cohort 2, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline active control group. Around 395 adult participants with moderate to severe atrophic acne scarring on both cheeks will be screened in the study in approximately 25 sites in the United States. Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Participants in general good health, and seeking improvement of atrophic acne scars.

• Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan Acne Scar Improvement Scale \[ASIS\]) on each cheek based on evaluating investigator (EI) live assessment (both cheeks must qualify but do not need to have the same score) at the first Screening Visit.

• At least 5 rolling or boxcar-type acne scars in total within the predefined 4 cm × 4 cm assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator (TI).

Locations
United States
Arizona
Advanced Research Associates - Glendale /ID# 254961
RECRUITING
Glendale
California
Marcus Facial Plastic Surgery /ID# 275880
RECRUITING
Redondo Beach
Pacific Clinical Innovations /ID# 256185
RECRUITING
Vista
Connecticut
DMR Research PLLC /ID# 256199
RECRUITING
Westport
Georgia
Hamilton Research, LLC /ID# 256925
RECRUITING
Alpharetta
Maryland
Aesthetic Center at Woodholme /ID# 256197
RECRUITING
Baltimore
North Carolina
Wilmington Dermatology Center /ID# 256192
RECRUITING
Wilmington
New York
The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182
RECRUITING
Mount Kisco
Texas
Austin Institute for Clinical Research - Pflugerville /ID# 256200
RECRUITING
Pflugerville
Virginia
SkinDC /ID# 254962
RECRUITING
Arlington
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2029-11
Participants
Target number of participants: 395
Treatments
Experimental: Cohort 1: Open-Label ELAPR002f Injectable Gel
Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.
Experimental: Cohort 2: ELAPR002f Injectable Gel
Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.
Experimental: Cohort 2: Saline Control
Participants will receive a saline control on Days 1, 31, and 61. Participants will be followed for up to 420 days.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov