Actively Recruiting
A Multicenter, Double-blind, Randomized Study to Evaluate Safety and Effectiveness of ELAPR002f Injectable Gel in Adults With Atrophic Acne Scars
Led by AbbVie · Updated on 2025-11-24
395
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of ELAPR002f injectable gel in adults with moderate to severe atrophic acne scars. These scars are flat or indented marks that remain after acne heals and can affect quality of life through reduced self-esteem and embarrassment. The study is a controlled, randomized trial including about 395 adults with scarring on both cheeks, conducted at multiple sites in the United States. Participants are divided into two cohorts. Cohort 1 receives ELAPR002f injectable gel openly, while Cohort 2 participants are randomly assigned to receive either ELAPR002f gel or a saline control via intradermal injections. Treatments are given on Days 1, 31, and 61. After the three treatment sessions over two months, participants are followed for up to 12 months to observe outcomes and any side effects. During the study, participants will have regular visits at a clinic or hospital for medical assessments, blood tests, and questionnaires to monitor their progress and any side effects. Researchers will measure the percentage of participants who achieve at least a 20% reduction in acne scar area and various safety parameters, including injection site responses and changes in vital signs and laboratory values. The total study duration for each participant can be up to 420 days.
CONDITIONS
Brief Title
A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be in generally 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) on both cheeks.
- At least 5 rolling or boxcar-type acne scars within a 4 cm by 4 cm area on either cheek with otherwise healthy skin.
You will not qualify if you...
- Presence of clinically significant active acne on the face.
- Current inflammatory or infectious skin conditions on the face other than acne, including herpes, rosacea, abscess, unhealed wounds, or cancerous/pre-cancerous lesions.
- Predominantly ice pick type acne scars.
- History of keloid or hypertrophic scarring, or post-inflammatory pigmentation changes (hyperpigmentation or hypopigmentation).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants receive intradermal injections of ELAPR002f Injectable Gel or saline control on Days 1, 31, and 61 to treat atrophic acne scars.
3 treatment visits (in-person)
Duration - Up to 420 days
Participants are followed for safety and effectiveness assessments after treatment.
Multiple follow-up visits over 14 months
Trial Site Locations
Total: 10 locations
1
Advanced Research Associates - Glendale /ID# 254961
Glendale, Arizona, United States, 85308
Actively Recruiting
2
Marcus Facial Plastic Surgery /ID# 275880
Redondo Beach, California, United States, 90277
Actively Recruiting
3
Pacific Clinical Innovations /ID# 256185
Vista, California, United States, 92083-6030
Actively Recruiting
4
DMR Research PLLC /ID# 256199
Westport, Connecticut, United States, 06880
Actively Recruiting
5
Hamilton Research, LLC /ID# 256925
Alpharetta, Georgia, United States, 30022
Actively Recruiting
6
Aesthetic Center at Woodholme /ID# 256197
Baltimore, Maryland, United States, 21208-6391
Actively Recruiting
7
The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182
Mount Kisco, New York, United States, 10549-3028
Actively Recruiting
8
Wilmington Dermatology Center /ID# 256192
Wilmington, North Carolina, United States, 28403
Actively Recruiting
9
Austin Institute for Clinical Research - Pflugerville /ID# 256200
Pflugerville, Texas, United States, 78660
Actively Recruiting
10
SkinDC /ID# 254962
Arlington, Virginia, United States, 22209
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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