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NCT07207369 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
A Phase 3 study of Acne Scars, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 395
- Enrollment target
- 10
- Study locations
NCT07207369: Recruiting Phase 3 study of Acne Scars, sponsored by AbbVie.
NCT07207369 is a Phase 3 study of Acne Scars that is actively recruiting participants, run by AbbVie. The registered enrollment target is 395 participants, above the 20-participant average among 6 other Acne Scars trials with a reported enrollment target (1875% higher). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07207369, a Phase 3 study of Acne Scars, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 395 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
The acne scar area is calculated from 3D camera imaging software. Area is defined as the sum of the individual scar area of the 5 most prominent scars identified by the treating investigator (TI).
Conditions Studied
Interventions
- DEVICE ELAPR002f Injectable Gel
- DEVICE Saline Control
Study Locations (10)
California
- Marcus Facial Plastic Surgery /ID# 275880 - Redondo Beach
- Pacific Clinical Innovations /ID# 256185 - Vista
Arizona
- Advanced Research Associates - Glendale /ID# 254961 - Glendale
Connecticut
- DMR Research PLLC /ID# 256199 - Westport
Georgia
- Hamilton Research, LLC /ID# 256925 - Alpharetta
Maryland
- Aesthetic Center at Woodholme /ID# 256197 - Baltimore
New York
- The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182 - Mount Kisco
North Carolina
- Wilmington Dermatology Center /ID# 256192 - Wilmington
Texas
- Austin Institute for Clinical Research - Pflugerville /ID# 256200 - Pflugerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2029-11 |
| Phase | Phase 3 |
What NCT07207369 shows while recruiting
NCT07207369 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, above the 20-participant average among 6 other Acne Scars trials with a reported enrollment target (1875% higher).
The record links to 1 condition, with Acne Scars appearing as the primary indexed condition, and to 2 interventions - of which ELAPR002f Injectable Gel is the first listed.
NCT07207369 lists 10 locations in 9 states (California, Arizona, Connecticut).
Frequently Asked Questions
What is clinical trial NCT07207369 about?
NCT07207369 is a clinical study titled "A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars". 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...
What is the current status of trial NCT07207369?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2025-10-24. Estimated completion is 2029-11.
What conditions does trial NCT07207369 study?
This clinical trial studies the following conditions: Acne Scars.
What interventions are being tested in trial NCT07207369?
The interventions under investigation include: ELAPR002f Injectable Gel (DEVICE), Saline Control (DEVICE).
Who is sponsoring clinical trial NCT07207369?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07207369 being conducted?
This trial has 10 study locations across Arizona, California, Connecticut, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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