ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

Last updated: August 7, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Saline Active Control

ELAPR002f Injectable Gel

Saline Control

Clinical Study ID

NCT05995340
2015-702-008
CIV-23-03-042622
  • Ages > 18
  • All Genders

Study Summary

Visit the study website https://dawnacnescarstudy.com/ACT for more information. 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. 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 156 adult participants with moderate to severe atrophic acne scarring on both cheeks will be enrolled in the study in approximately 12 sites in Germany and Canada.

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, with no active COVID-19 infection, and seekingimprovement of atrophic acne scars.

  • Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan ASIS) oneach cheek based on Evaluating Investigator's live assessment (both cheeks mustqualify 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 predefinedassessment field of either cheek in areas of otherwise normal healthy skin, asassessed by the treating investigator.

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.

  • History of granulomatous or connective tissue disease.

  • Diagnosed autoimmune disease (eg, Type 1 diabetes, rheumatoid arthritis,scleroderma, vitiligo).

  • Diagnosed history of lung disease.

  • Known hypersensitivity to the constituents of the device.

  • Visual acuity of 20/100 or worse or abnormal confrontational visual fields or ocularmotility.

Study Design

Total Participants: 156
Treatment Group(s): 3
Primary Treatment: Saline Active Control
Phase: 3
Study Start date:
November 21, 2023
Estimated Completion Date:
February 16, 2026

Connect with a study center

  • Alberta DermaSurgery Centre /ID# 243168

    Edmonton, Alberta T6G 1C3
    Canada

    Active - Recruiting

  • Humphrey & Beleznay Cosmetic Dermatology /ID# 266634

    Vancouver, British Columbia V5Z 4E1
    Canada

    Active - Recruiting

  • Pacific Derm /ID# 227467

    Vancouver, British Columbia V6H 4E1
    Canada

    Active - Recruiting

  • Dermetics Cosmetic Dermatology /ID# 227469

    Burlington, Ontario L7N 3N2
    Canada

    Active - Recruiting

  • The Centre for Clinical Trials /ID# 233841

    Oakville, Ontario L6J 7W5
    Canada

    Active - Recruiting

  • The Center For Dermatology /ID# 227470

    Richmond Hill, Ontario L4B 1A5
    Canada

    Active - Recruiting

  • Bertucci MedSpa Inc. /ID# 227468

    Woodbridge, Ontario L4L 8E2
    Canada

    Active - Recruiting

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 262566

    Blankenfelde-Mahlow, Brandenburg 15831
    Germany

    Active - Recruiting

  • Rosenpark Research /ID# 227471

    Darmstadt, Hessen 64283
    Germany

    Active - Recruiting

  • Privatpraxis Dr. Hilton & Partner /ID# 227472

    Duesseldorf, Nordrhein-Westfalen 40212
    Germany

    Active - Recruiting

  • Hautok and Hautok-cosmetics /ID# 227474

    Muenchen, Saarland 80333
    Germany

    Active - Recruiting

  • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 227475

    Oberursel, Saarland 61440
    Germany

    Active - Recruiting

  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 262566

    Mahlow, 15831
    Germany

    Site Not Available

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