A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
AbbVie · NCT07207369
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 395
- US sites recruiting
- 10
- Study start
- October 24, 2025
- Record last updated
- November 24, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ELAPR002f Injectable Gel; Saline Control
Conditions: Acne Scars
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- The participant has clinically significant acne on the face.
- 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.
Recruiting US locations
Advanced Research Associates - Glendale /ID# 254961
Glendale, AZ 85308
Marcus Facial Plastic Surgery /ID# 275880
Redondo Beach, CA 90277
Pacific Clinical Innovations /ID# 256185
Vista, CA 92083-6030
DMR Research PLLC /ID# 256199
Westport, CT 06880
Hamilton Research, LLC /ID# 256925
Alpharetta, GA 30022
Aesthetic Center at Woodholme /ID# 256197
Baltimore, MD 21208-6391
The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182
Mount Kisco, NY 10549-3028
Wilmington Dermatology Center /ID# 256192
Wilmington, NC 28403
Austin Institute for Clinical Research - Pflugerville /ID# 256200
Pflugerville, TX 78660
SkinDC /ID# 254962
Arlington, VA 22209
Study contacts (from the official record)
- ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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