Acne ScarsPhase 3NCT07207369
A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
A Phase 3 study testing ELAPR002f Injectable Gel in people with Acne Scars, run by AbbVie at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Acne Scars
- What is being tested?
- ELAPR002f Injectable Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 10 sitesUnited States
- Study dates
- 24 Oct 2025to Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Hamilton Research, LLC /ID# 256925
Alpharetta, Georgia, 30022
- Recruiting
SkinDC /ID# 254962
Arlington, Virginia, 22209
- Recruiting
Aesthetic Center at Woodholme /ID# 256197
Baltimore, Maryland, 21208-6391
- Recruiting
Advanced Research Associates - Glendale /ID# 254961
Glendale, Arizona, 85308
- Recruiting
The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182
Mount Kisco, New York, 10549-3028
- Recruiting
Austin Institute for Clinical Research - Pflugerville /ID# 256200
Pflugerville, Texas, 78660
- Recruiting
Marcus Facial Plastic Surgery /ID# 275880
Redondo Beach, California, 90277
- Recruiting
Pacific Clinical Innovations /ID# 256185
Vista, California, 92083-6030
- Recruiting
DMR Research PLLC /ID# 256199
Westport, Connecticut, 06880
- Recruiting
Wilmington Dermatology Center /ID# 256192
Wilmington, North Carolina, 28403
About this study
Official title: A Multicenter, Cohort-design, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
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.
Read more
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
- Being tested
- ELAPR002f Injectable Gel, Saline Control
- Keywords
- Acne Scars, ELAPR002f injectable gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELAPR002f Injectable GelDevice
Intradermal Injections
Saline ControlDevice
Intradermal Injections
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Saline Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 420
Secondary outcomes (7)
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire
The ACNE-Q Acne Scars questionnaire includes 10 questions that ask how much the participant is bothered by their acne scars on a 4-point scale ranging from 1=Not at all to 4=Very Much.
Measured: Up to Day 420
Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress
ACNE-Q - Appearance-Related Distress questionnaire includes 8 questions that ask about how the participants describe themselves on a 4-point scale ranging from 1=Never to 4=Always.
Measured: Up to Day 420
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score
FACE-Q Satisfaction With Skin questionnaire includes 12 questions that ask how much the participants are satisfied or dissatisfied with their facial skin on a 4-point scale ranging from 1=Very Dissatisfied to 4=Very Satisfied.
Measured: 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
A "responder" is a participant who achieves 1-grade improvement on either cheek based on the ASIS, as assessed by the EI. The ASIS is a 5-grade scale used to assess acne scar improvement ranging from 1=Almost None to 5=Severe. Each side of the face is scored separately.
Measured: Up to Day 420
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).
Measured: Up to Day 420
Percent Change from Baseline in Acne Scar Area
The acne scar area is measured by 3D camera imaging software. Area is defined as the sum of the individual scar area of the 5 most prominent scars identified by the TI.
Measured: Up to Day 420
Percent Change from Baseline in Acne Scar Volume
The acne scar volume is measured by 3D camera imaging software. Volume is defined as the sum of the individual scar volume of the 5 most prominent scars identified by the TI.
Measured: Up to Day 420
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start24 Oct 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207369
- Sponsor's protocol ID
- 2015-701-008
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Cohort-design, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
- ClinicalTrials.gov ID
- NCT07207369
- Acronym / sponsor ID
- 2015-701-008
- Conditions
- Acne Scars
- Keywords
- Acne Scars, ELAPR002f injectable gel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Open-Label ELAPR002f Injectable Gel | Experimental | Device: ELAPR002f Injectable GelParticipants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days. |
| Cohort 2: ELAPR002f Injectable Gel | Experimental | Device: ELAPR002f Injectable GelParticipants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days. |
| Cohort 2: Saline Control | Experimental | Device: Saline ControlParticipants will receive a saline control on Days 1, 31, and 61. Participants will be followed for up to 420 days. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELAPR002f Injectable GelIntradermal Injections | Device | Cohort 1: Open-Label ELAPR002f Injectable Gel, Cohort 2: ELAPR002f Injectable Gel |
| Saline ControlIntradermal Injections | Device | Cohort 2: Saline Control |
Primary outcome
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.
7 secondary outcomes
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire
Time frame: Up to Day 420
Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress
Time frame: Up to Day 420
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score
Time frame: 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
Time frame: Up to Day 420
Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area
Time frame: Up to Day 420
Percent Change from Baseline in Acne Scar Area
Time frame: Up to Day 420
Percent Change from Baseline in Acne Scar Volume
Time frame: Up to Day 420
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ELAPR002f Injectable Gel in people with Acne Scars, run by AbbVie at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area (time frame: Baseline to Day 181). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.