Recruiting
Phase 3

ELAPR002f

Sponsor:

AbbVie

Code:

NCT07207369

Conditions

Acne Scars

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

ELAPR002f Injectable Gel

Saline Control

Study Details

Brief 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.

Conditions

Acne Scars

Study ID

NCT07207369

Start date

Oct 24, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

395 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Open-Label ELAPR002f Injectable Gel

Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.

experimental: Cohort 2: ELAPR002f Injectable Gel

Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.

experimental: Cohort 2: Saline Control

Participants will receive a saline control on Days 1, 31, and 61. Participants will be followed for up to 420 days.

Interventions

ELAPR002f Injectable Gel

Intradermal Injections

Saline Control

Intradermal Injections

Primary outcome measure

  • Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area [ Time Frame: Baseline to Day 181 ]
  • Number of Participants with Adverse Events [ Time Frame: Up to Day 420 ]
  • Number of Participants with Presence of Binding Antibodies [ Time Frame: Up to Day 420 ]
  • Number of Participants with Injection Site Responses (ISRs) and Systemic Responses [ Time Frame: Up to Day 420 ]
  • Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters [ Time Frame: Up to Day 420 ]
  • Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters [ Time Frame: Up to Day 420 ]
  • Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements [ Time Frame: Up to Day 420 ]
  • Change from Baseline Procedure Pain [ Time Frame: Up to Day 420 ]
  • Number of Participants with a Positive Skin Test [ Time Frame: Up to Day 420 ]
  • Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion [ Time Frame: Up to Day 420 ]
  • Number of Participants Needing a Histology of Volar Forearm Site Biopsy [ Time Frame: Up to Day 420 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Advanced Research Associates - Glendale /ID# 254961

Recruiting

Glendale, Arizona, United States, 85308

Marcus Facial Plastic Surgery /ID# 275880

Recruiting

Redondo Beach, California, United States, 90277

Pacific Clinical Innovations /ID# 256185

Recruiting

Vista, California, United States, 92083-6030

DMR Research PLLC /ID# 256199

Recruiting

Westport, Connecticut, United States, 06880

Hamilton Research, LLC /ID# 256925

Recruiting

Alpharetta, Georgia, United States, 30022

Aesthetic Center at Woodholme /ID# 256197

Recruiting

Baltimore, Maryland, United States, 21208-6391

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

Recruiting

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

Wilmington Dermatology Center /ID# 256192

Recruiting

Wilmington, North Carolina, United States, 28403

Austin Institute for Clinical Research - Pflugerville /ID# 256200

Recruiting

Pflugerville, Texas, United States, 78660

SkinDC /ID# 254962

Recruiting

Arlington, Virginia, United States, 22209

More Information

Sponsor

AbbVie

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Acne Scars
  • ELAPR002f injectable gel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2025-11-24.