ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

Study Overview
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Brief Summary
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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. 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 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 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.

Official Title
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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

Conditions
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Atrophic Acne Scars

Intervention / Treatment
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* Device: ELAPR002f Injectable Gel
* Other: Saline Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: The participant has active/ongoing acne lesions 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). Diagnosed history of asthma. Known hypersensitivity to the constituents of the device. Visual acuity of 20/100 or worse or abnormal confrontational visual fields or ocular motility.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELAPR002f Injectable Gel<br>Participants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face. | Device: ELAPR002f Injectable Gel<br>* Intradermal Injections<br>|
| Other: Saline Control<br>Participants will receive 3 treatments of Saline Control into the cheek area on each side of the face. | Other: Saline Control<br>* Intradermal Injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline 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, 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. | 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, urinalysis and prolactin. 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrophic Acne Scars, ELAPR002f injectable gel