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

Study Identifier
2015-701-008
CT.gov Identifier
NCT07207369
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    22+ years
    Inclusion and 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.

    Protocol 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 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 in 4 chance that participants will be assigned to the saline active control group. Around 395 adult participants with moderate to severe atrophic acne scarring on both cheeks will be screened in the study in approximately 25 sites in the United States.

    Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 months.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Advanced Research Associates - Glendale /ID# 254961
    Glendale, Arizona, United States, 85308
    Status
    Recruiting
    Location
    Marcus Facial Plastic Surgery /ID# 275880
    Redondo Beach, California, United States, 90277
    Status
    Recruiting
    Location
    Pacific Clinical Innovations /ID# 256185
    Vista, California, United States, 92083-6030
    Status
    Recruiting
    Location
    DMR Research PLLC /ID# 256199
    Westport, Connecticut, United States, 06880
    Status
    Recruiting
    Location
    Hamilton Research, LLC /ID# 256925
    Alpharetta, Georgia, United States, 30022
    Status
    Recruiting
    Location
    Aesthetic Center at Woodholme /ID# 256197
    Baltimore, Maryland, United States, 21208-6391
    Status
    Recruiting
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