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

Last updated: November 20, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Saline Control

ELAPR002f Injectable Gel

Clinical Study ID

NCT07207369
2015-701-008
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ScarImprovement Scale [ASIS]) on each cheek based on evaluating investigator (EI) liveassessment (both cheeks must qualify but do not need to have the same score) at thefirst Screening Visit.

  • At least 5 rolling or boxcar-type acne scars in total within the predefined 4 cm × 4cm assessment field of either cheek in areas of otherwise normal healthy skin, asassessed by the treating investigator (TI).

Exclusion

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 precancerouslesion, on the face.

  • The participant presents with predominantly ice pick scars.

  • History of keloid scar formation, hypertrophic scarring, and/or post inflammatoryhyperpigmentation or hypopigmentation.

Study Design

Total Participants: 395
Treatment Group(s): 2
Primary Treatment: Saline Control
Phase: 3
Study Start date:
October 24, 2025
Estimated Completion Date:
November 30, 2029

Connect with a study center

  • Advanced Research Associates - Glendale /ID# 254961

    Glendale 5295985, Arizona 5551752 85308
    United States

    Active - Recruiting

  • Marcus Facial Plastic Surgery /ID# 275880

    Redondo Beach 5386785, California 5332921 90277
    United States

    Active - Recruiting

  • Pacific Clinical Innovations /ID# 256185

    Vista 5406602, California 5332921 92083-6030
    United States

    Active - Recruiting

  • DMR Research PLLC /ID# 256199

    Westport 4845585, Connecticut 4831725 06880
    United States

    Active - Recruiting

  • Hamilton Research, LLC /ID# 256925

    Alpharetta 4179574, Georgia 4197000 30022
    United States

    Active - Recruiting

  • Aesthetic Center at Woodholme /ID# 256197

    Baltimore 4347778, Maryland 4361885 21208-6391
    United States

    Active - Recruiting

  • The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182

    Mount Kisco 5127744, New York 5128638 10549-3028
    United States

    Active - Recruiting

  • Wilmington Dermatology Center /ID# 256192

    Wilmington 4499379, North Carolina 4482348 28403
    United States

    Active - Recruiting

  • Austin Institute for Clinical Research - Pflugerville /ID# 256200

    Pflugerville 4718711, Texas 4736286 78660
    United States

    Active - Recruiting

  • SkinDC /ID# 254962

    Arlington 4744709, Virginia 6254928 22209
    United States

    Active - Recruiting

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