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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
395
Intradermal Injections
Intradermal Injections
Advanced Research Associates - Glendale /ID# 254961
Glendale, Arizona, United States
RECRUITINGMarcus Facial Plastic Surgery /ID# 275880
Redondo Beach, California, United States
RECRUITINGPacific Clinical Innovations /ID# 256185
Vista, California, United States
RECRUITINGDMR Research PLLC /ID# 256199
Westport, Connecticut, United States
RECRUITINGHamilton Research, LLC /ID# 256925
Alpharetta, Georgia, United States
RECRUITINGAesthetic Center at Woodholme /ID# 256197
Baltimore, Maryland, United States
RECRUITINGThe Center for Dermatology Cosmetics & Laser Surgery /ID# 256182
Mount Kisco, New York, United States
RECRUITINGWilmington Dermatology Center /ID# 256192
Wilmington, North Carolina, United States
RECRUITINGAustin Institute for Clinical Research - Pflugerville /ID# 256200
Pflugerville, Texas, United States
RECRUITINGSkinDC /ID# 254962
Arlington, Virginia, United States
RECRUITINGPercentage 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 420
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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).
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: Up to Day 420