Status:
RECRUITING
A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
Lead Sponsor:
AbbVie
Conditions:
Acne Scars
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief 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 signif...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT07207369
Start Date
October 24 2025
End Date
November 1 2029
Last Update
November 24 2025
Active Locations (10)
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1
Advanced Research Associates - Glendale /ID# 254961
Glendale, Arizona, United States, 85308
2
Marcus Facial Plastic Surgery /ID# 275880
Redondo Beach, California, United States, 90277
3
Pacific Clinical Innovations /ID# 256185
Vista, California, United States, 92083-6030
4
DMR Research PLLC /ID# 256199
Westport, Connecticut, United States, 06880