ELAPR002f injectable gel for adult atrophic acne scars
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
This study will test whether ELAPR002f injectable gel can safely fill and improve atrophic acne scars in adults with moderate to severe scarring.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 395 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 10 sites (Glendale, Arizona and 9 other locations) |
| Trial ID | NCT07207369 on ClinicalTrials.gov |
What this trial studies
This Phase 3, interventional study enrolls adults with moderate to severe atrophic acne scarring on both cheeks to receive injections of ELAPR002f or saline control. There are two cohorts: Cohort 1 receives ELAPR002f, and Cohort 2 randomizes participants between ELAPR002f and a saline active control with about a 1 in 4 chance of receiving saline. Around 395 participants are expected overall, and investigators will use live assessments including the Allergan Acne Scar Improvement Scale and a predefined 4 cm × 4 cm assessment field to select and evaluate scars. Safety and effectiveness endpoints will compare scar filling and adverse events over the study follow-up period.
Who should consider this trial
Good fit: Adults in generally good health with moderate to severe atrophic acne scarring (ASIS grade 4 or 5) on both cheeks and at least five rolling or boxcar scars within a 4×4 cm area are the intended participants.
Not a fit: People with predominantly ice pick scars, active facial acne, a history of keloid or hypertrophic scarring, or current facial inflammatory or infectious skin conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ELAPR002f could provide immediate filling and visible improvement of atrophic acne scars, potentially improving appearance and related quality of life.
How similar studies have performed: Dermal filler approaches have previously produced aesthetic improvements for atrophic acne scars, but ELAPR002f is an investigational device and requires Phase 3 data to confirm its safety and effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Glendale, Arizona and 9 other locations
- Advanced Research Associates - Glendale /ID# 254961 — Glendale, Arizona, United States (Recruiting)
- Marcus Facial Plastic Surgery /ID# 275880 — Redondo Beach, California, United States (Recruiting)
- Pacific Clinical Innovations /ID# 256185 — Vista, California, United States (Recruiting)
- DMR Research PLLC /ID# 256199 — Westport, Connecticut, United States (Recruiting)
- Hamilton Research, LLC /ID# 256925 — Alpharetta, Georgia, United States (Recruiting)
- Aesthetic Center at Woodholme /ID# 256197 — Baltimore, Maryland, United States (Recruiting)
- The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182 — Mount Kisco, New York, United States (Recruiting)
- Wilmington Dermatology Center /ID# 256192 — Wilmington, North Carolina, United States (Recruiting)
- Austin Institute for Clinical Research - Pflugerville /ID# 256200 — Pflugerville, Texas, United States (Recruiting)
- SkinDC /ID# 254962 — Arlington, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.