NCT07207369 · AbbVie
A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
What this study is about
Atrophic acne scars are flat, indented or with an inverted center scars that develop at the goal measurement 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.
View original scientific description
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.
Interventions
DEVICE
ELAPR002f Injectable Gel
Intradermal Injections
DEVICE
Saline Control
Intradermal Injections
Primary outcome measures
Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area
Time frame: Baseline to Day 181
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).
Number of Participants with Adverse Events
Time frame: Up to Day 420
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.
Number of Participants with Presence of Binding Antibodies
Time frame: Up to Day 420
Presence of binding antibodies followed by characterization through isotyping and evaluation of cross-reactivity to endogenous tissues.
Number of Participants with Injection Site Responses (ISRs) and Systemic Responses
Time frame: Up to Day 420
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).
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Time frame: Up to Day 420
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.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Time frame: Up to Day 420
Clinical laboratory parameters include tests of hematology, chemistry, and urinalysis. The investigator will assess the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements
Time frame: Up to Day 420
Physical measurements include weight and BMI. The investigator will assess the results for clinical significance.
Change from Baseline Procedure Pain
Time frame: Up to Day 420
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.
Number of Participants with a Positive Skin Test
Time frame: Up to Day 420
Participants will undergo a skin test in the volar area of the forearm to test for hypersensitivity.
Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion
Time frame: Up to Day 420
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.
Number of Participants Needing a Histology of Volar Forearm Site Biopsy
Time frame: Up to Day 420
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Glendale, Arizona
- Redondo Beach, California
- Vista, California
- Westport, Connecticut
- Alpharetta, Georgia
- Baltimore, Maryland
- Mount Kisco, New York
- Wilmington, North Carolina
- Pflugerville, Texas
- Arlington, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2025 · Source of record for eligibility and locations