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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELAPR002f Injectable Gel | Device | Intradermal Injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 420 |
| Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 254961 | Recruiting | Glendale | Arizona | 85308 | United States | |
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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Saline Control | Device | Intradermal Injections |
|
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 |
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. |
| 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. | 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. | 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). | 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. | 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. | Up to Day 420 |
| Marcus Facial Plastic Surgery /ID# 275880 |
| Recruiting |
| Redondo Beach |
| California |
| 90277 |
| United States |
| Pacific Clinical Innovations /ID# 256185 | Recruiting | Vista | California | 92083-6030 | United States |
| DMR Research PLLC /ID# 256199 | Recruiting | Westport | Connecticut | 06880 | United States |
| Hamilton Research, LLC /ID# 256925 | Recruiting | Alpharetta | Georgia | 30022 | United States |
| Aesthetic Center at Woodholme /ID# 256197 | Recruiting | Baltimore | Maryland | 21208-6391 | United States |
| The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182 | Recruiting | Mount Kisco | New York | 10549-3028 | United States |
| Wilmington Dermatology Center /ID# 256192 | Recruiting | Wilmington | North Carolina | 28403 | United States |
| Austin Institute for Clinical Research - Pflugerville /ID# 256200 | Recruiting | Pflugerville | Texas | 78660 | United States |
| SkinDC /ID# 254962 | Recruiting | Arlington | Virginia | 22209 | United States |