Atrophic Acne ScarsPhase 3NCT05995340
ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars
A Phase 3 study testing ELAPR002f Injectable Gel in people with Atrophic Acne Scars, run by AbbVie at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic 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
- 157 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 21 Nov 2023to 14 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in general good health, with no active COVID-19 infection, and seeking improvement of atrophic acne scars.
- Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan ASIS) on each cheek based on Evaluating Investigator's 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 assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator.
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.
- History of granulomatous or connective tissue disease.
- Diagnosed autoimmune disease (eg, Type 1 diabetes, rheumatoid arthritis, scleroderma, vitiligo).
Show all 9Show fewer
- 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 ocular motility.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada7 sites
Dermetics Cosmetic Dermatology /ID# 227469
Burlington, Ontario, L7N 3N2
Alberta DermaSurgery Centre /ID# 243168
Edmonton, Alberta, T6G 1C3
The Centre For Clinical Trials /ID# 233841
Oakville, Ontario, L6J 7W5
The Center For Dermatology /ID# 227470
Richmond Hill, Ontario, L4B 1A5
Humphrey & Beleznay Cosmetic Dermatology /ID# 266634
Vancouver, British Columbia, V5Z 4E1
Pacific Derm /ID# 227467
Vancouver, British Columbia, V6H 4E1
Bertucci MedSpa Inc. /ID# 227468
Woodbridge, Ontario, L4L 8E2
Germany5 sites
Dermatologie Mahlow /ID# 262566
Blankenfelde-Mahlow, Brandenburg, 15831
Rosenpark Research /ID# 227471
Darmstadt, Hesse, 64283
Privatpraxis Dr. Hilton & Partner /ID# 227472
Düsseldorf, North Rhine-Westphalia, 40212
MVZ Corius MediCorium GmbH /ID# 227475
Friedrichsdorf, Hesse, 61381
Hautok and Hautok-cosmetics /ID# 227474
Munich, Bavaria, 80333
About this study
Official title: An International, Multicenter, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
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.
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
- Atrophic Acne Scars
- Being tested
- ELAPR002f Injectable Gel, Saline Active Control
- Keywords
- Atrophic 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 Active ControlOther
Intradermal Injections
| Study group | Role | What they receive |
|---|---|---|
| Saline Active Control | Other | Participants will receive 3 treatments of Saline Active Control into the cheek area on each side of the face. Receives: Other: Saline Active Control |
| ELAPR002f Injectable Gel | Experimental | Participants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face. Receives: Device: ELAPR002f Injectable Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving "Responder" Status Based on the Allergan Acne Scar Improvement Scale (ASIS)
A "responder" is a participant who achieves at least a 1-grade improvement on both cheeks 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: Baseline to Day 181
Number of Participants with Adverse Events
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved.
Measured: Up to Day 420
Number of Participants with Presence of Binding Antibodies
Presence of binding antibodies
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 for up to 30 consecutive days after each of the 3 treatment sessions starting on the day of injection. 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 61
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 30
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
Secondary outcomes (4)
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Scale
The ACNE-Q Acne Scars scale 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 Scale
ACNE-Q - Appearance-Related Distress scale includes 10 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 Scale
FACE-Q Satisfaction With Skin scale 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 Based on the ASIS
A "responder" is a participant who achieves at least a 1-grade improvement on both cheeks 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start21 Nov 2023
- Primary completion14 Jul 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic 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
- 157 participants (actual)
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
- NCT05995340
- Sponsor's protocol ID
- 2015-702-008
- Other IDs
- CIV-23-03-042622
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, 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
- NCT05995340
- Acronym / sponsor ID
- 2015-702-008
- Conditions
- Atrophic Acne Scars
- Keywords
- Atrophic Acne Scars, ELAPR002f injectable gel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 16 Aug 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Active Control | Other | Other: Saline Active ControlParticipants will receive 3 treatments of Saline Active Control into the cheek area on each side of the face. |
| ELAPR002f Injectable Gel | Experimental | Device: ELAPR002f Injectable GelParticipants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants in general good health, with no active COVID-19 infection, and seeking improvement of atrophic acne scars.
- Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan ASIS) on each cheek based on Evaluating Investigator's 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 assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator.
Key exclusion criteria (9 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.
- History of granulomatous or connective tissue disease.
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 | ELAPR002f Injectable Gel |
| Saline Active ControlIntradermal Injections | Other | Saline Active Control |
Primary outcome
Percentage of Participants Achieving "Responder" Status Based on the Allergan Acne Scar Improvement Scale (ASIS)
Time frame: Baseline to Day 181
A "responder" is a participant who achieves at least a 1-grade improvement on both cheeks 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.
Number of Participants with Adverse Events
Time frame: Up to Day 420
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical device. This definition includes events related to the investigational medical device or comparator and events related to the procedures involved.
Number of Participants with Presence of Binding Antibodies
Time frame: Up to Day 420
Presence of binding antibodies
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 for up to 30 consecutive days after each of the 3 treatment sessions starting on the day of injection. 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 61
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 30
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,
4 secondary outcomes
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Scale
Time frame: Up to Day 420
Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress Scale
Time frame: Up to Day 420
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale
Time frame: Up to Day 420
Percentage of Participants Achieving "Responder" Status Based on the ASIS
Time frame: Up to Day 420
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- 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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
12 sites in 2 countries: 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 Atrophic Acne Scars, run by AbbVie at 12 sites in 2 countries.
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 9 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: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving "Responder" Status Based on the Allergan Acne Scar Improvement Scale (ASIS) (time frame: Baseline to Day 181). The study lists 10 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 17 Aug 2026.