A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
NCT ID: NCT07207369
Last Updated: 2025-11-24
Study Results
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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RECRUITING
PHASE3
395 participants
INTERVENTIONAL
2025-10-24
2029-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
ELAPR002f Injectable Gel
Intradermal Injections
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.
ELAPR002f Injectable Gel
Intradermal Injections
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.
Saline Control
Intradermal Injections
Interventions
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ELAPR002f Injectable Gel
Intradermal Injections
Saline Control
Intradermal Injections
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Current cutaneous or mucosal inflammatory or infectious processes other than acne (eg, herpes), rosacea, abscess, an unhealed wound, or a cancerous or precancerous lesion, on the face.
* The participant presents with predominantly ice pick scars.
* History of keloid scar formation, hypertrophic scarring, and/or post inflammatory hyperpigmentation or hypopigmentation.
22 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Advanced Research Associates - Glendale /ID# 254961
Glendale, Arizona, United States
Marcus Facial Plastic Surgery /ID# 275880
Redondo Beach, California, United States
Pacific Clinical Innovations /ID# 256185
Vista, California, United States
DMR Research PLLC /ID# 256199
Westport, Connecticut, United States
Hamilton Research, LLC /ID# 256925
Alpharetta, Georgia, United States
Aesthetic Center at Woodholme /ID# 256197
Baltimore, Maryland, United States
The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182
Mount Kisco, New York, United States
Wilmington Dermatology Center /ID# 256192
Wilmington, North Carolina, United States
Austin Institute for Clinical Research - Pflugerville /ID# 256200
Pflugerville, Texas, United States
SkinDC /ID# 254962
Arlington, Virginia, United States
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2015-701-008
Identifier Type: -
Identifier Source: org_study_id
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