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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-23-03-042622 | Other Identifier | EUDAMED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Active Control | Other | Participants will receive 3 treatments of Saline Active Control into the cheek area on each side of the face. |
|
| ELAPR002f Injectable Gel | Experimental | Participants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELAPR002f Injectable Gel | Device | Intradermal Injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to Day 420 |
| Number of Participants with Presence of Binding Antibodies | Presence of binding antibodies | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 420 |
| Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta DermaSurgery Centre /ID# 243168 | Edmonton | Alberta | T6G 1C3 | Canada | ||
| Humphrey & Beleznay Cosmetic Dermatology /ID# 266634 |
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 Active Control |
| Other |
Intradermal Injections |
|
| 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 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. | 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, | Up to Day 420 |
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. |
| 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. | 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. | Up to Day 420 |
| Vancouver |
| British Columbia |
| V5Z 4E1 |
| Canada |
| Pacific Derm /ID# 227467 | Vancouver | British Columbia | V6H 4E1 | Canada |
| Dermetics Cosmetic Dermatology /ID# 227469 | Burlington | Ontario | L7N 3N2 | Canada |
| The Centre For Clinical Trials /ID# 233841 | Oakville | Ontario | L6J 7W5 | Canada |
| The Center For Dermatology /ID# 227470 | Richmond Hill | Ontario | L4B 1A5 | Canada |
| Bertucci MedSpa Inc. /ID# 227468 | Woodbridge | Ontario | L4L 8E2 | Canada |
| Hautok and Hautok-cosmetics /ID# 227474 | Munich | Bavaria | 80333 | Germany |
| Dermatologie Mahlow /ID# 262566 | Blankenfelde-Mahlow | Brandenburg | 15831 | Germany |
| Rosenpark Research /ID# 227471 | Darmstadt | Hesse | 64283 | Germany |
| MVZ Corius MediCorium GmbH /ID# 227475 | Friedrichsdorf | Hesse | 61381 | Germany |
| Privatpraxis Dr. Hilton & Partner /ID# 227472 | Düsseldorf | North Rhine-Westphalia | 40212 | Germany |