ELAPR002f injectable gel for adult atrophic acne scars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.