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โ† Trials
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A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars

RecruitingPhase 3Ages 22 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 i

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ร— 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.
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What it tests

  • ELAPR002f Injectable Gel
  • Saline Control
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Where

10 sites
Advanced Research Associates - Glendale /ID# 254961
Glendale, United States
Marcus Facial Plastic Surgery /ID# 275880
Redondo Beach, United States
Pacific Clinical Innovations /ID# 256185
Vista, United States
DMR Research PLLC /ID# 256199
Westport, United States
Hamilton Research, LLC /ID# 256925
Alpharetta, United States
Aesthetic Center at Woodholme /ID# 256197
Baltimore, United States
The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182
Mount Kisco, United States
Wilmington Dermatology Center /ID# 256192
Wilmington, United States

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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