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

NCT07207369 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: 2015-701-008
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 10

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

Keywords

Acne Scars; ELAPR002f injectable gel

Outcome Measures

Primary Outcomes (11)

• Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area

  The acne scar area is calculated from 3D camera imaging software. Area is defined as the sum of the individual scar area of the 5 most prominent scars identified by the treating investigator (TI).

  Baseline to Day 181

• Number of Participants with Adverse Events

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Day 420

• Number of Participants with Presence of Binding Antibodies

  Presence of binding antibodies followed by characterization through isotyping and evaluation of cross-reactivity to endogenous tissues.

  Up to Day 420

• Number of Participants with Injection Site Responses (ISRs) and Systemic Responses

  Incidence of ISRs/systemic responses as recorded by e-diary. ISRs are defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration (not redness or bruising).

  Up to Day 420

• Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters

  Vital sign parameters include body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.

  Up to Day 420

• Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

  Clinical laboratory parameters include tests of hematology, chemistry, and urinalysis. The investigator will assess the results for clinical significance.

  Up to Day 420

• Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements

  Physical measurements include weight and BMI. The investigator will assess the results for clinical significance.

  Up to Day 420

• Change from Baseline Procedure Pain

  Participants will assess procedure pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) after each of the 3 treatment sessions.

  Up to Day 420

• Number of Participants with a Positive Skin Test

  Participants will undergo a skin test in the volar area of the forearm to test for hypersensitivity.

  Up to Day 420

• Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion

  Number of participants with any acute cognitive changes or any change in confrontational visual fields, ocular motility, or a worsening (1-line change or more) on the Snellen visual acuity assessment.

  Up to Day 420

• Number of Participants Needing a Histology of Volar Forearm Site Biopsy

  Participants who are suspected of having a hypersensitivity reaction or have a hypersensitivity reaction to the volar forearm injection site will require a punch biopsy of the volar forearm injection site.

  Up to Day 420

Secondary Outcomes (7)

• Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire

  Up to Day 420

• Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress

  Up to Day 420

• Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score

  Up to Day 420

• Percentage of Participants Achieving "Responder" Status on Either Cheek Based on the Allergan Acne Scar Improvement Scale (ASIS), as assessed by the Evaluating Investigator

  Up to Day 420

• Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area

  Up to Day 420

Study Arms (3)

Cohort 1: Open-Label ELAPR002f Injectable Gel

EXPERIMENTAL

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

Device: ELAPR002f Injectable Gel

Cohort 2: ELAPR002f Injectable Gel

EXPERIMENTAL

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

Device: ELAPR002f Injectable Gel

Cohort 2: Saline Control

EXPERIMENTAL

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

Device: Saline Control

Interventions

ELAPR002f Injectable Gel DEVICE

Intradermal Injections

Cohort 1: Open-Label ELAPR002f Injectable Gel; Cohort 2: ELAPR002f Injectable Gel

Saline Control DEVICE

Intradermal Injections

Cohort 2: Saline Control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Advanced Research Associates - Glendale /ID# 254961

Glendale, Arizona, 85308, United States

RECRUITING

Marcus Facial Plastic Surgery /ID# 275880

Redondo Beach, California, 90277, United States

RECRUITING

Pacific Clinical Innovations /ID# 256185

Vista, California, 92083-6030, United States

RECRUITING

DMR Research PLLC /ID# 256199

Westport, Connecticut, 06880, United States

RECRUITING

Hamilton Research, LLC /ID# 256925

Alpharetta, Georgia, 30022, United States

RECRUITING

Aesthetic Center at Woodholme /ID# 256197

Baltimore, Maryland, 21208-6391, United States

RECRUITING

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

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

RECRUITING

Wilmington Dermatology Center /ID# 256192

Wilmington, North Carolina, 28403, United States

RECRUITING

Austin Institute for Clinical Research - Pflugerville /ID# 256200

Pflugerville, Texas, 78660, United States

RECRUITING

SkinDC /ID# 254962

Arlington, Virginia, 22209, United States

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 6, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (10)