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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
157
Intradermal Injections
Intradermal Injections
Alberta DermaSurgery Centre /ID# 243168
Edmonton, Alberta, Canada
Humphrey & Beleznay Cosmetic Dermatology /ID# 266634
Vancouver, British Columbia, Canada
Pacific Derm /ID# 227467
Vancouver, British Columbia, Canada
Dermetics Cosmetic Dermatology /ID# 227469
Burlington, Ontario, Canada
The Centre For Clinical Trials /ID# 233841
Oakville, Ontario, Canada
The Center For Dermatology /ID# 227470
Richmond Hill, Ontario, Canada
Bertucci MedSpa Inc. /ID# 227468
Woodbridge, Ontario, Canada
Hautok and Hautok-cosmetics /ID# 227474
Munich, Bavaria, Germany
Dermatologische Gemeinschaftspraxis Mahlow /ID# 262566
Blankenfelde-Mahlow, Brandenburg, Germany
Rosenpark Research /ID# 227471
Darmstadt, Hesse, Germany
...and 2 more locations
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).
Time frame: 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.
Time frame: Up to Day 420
Number of Participants with Presence of Binding Antibodies
Presence of binding antibodies
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 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).
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, urinalysis and prolactin. 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 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.
Time frame: 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,
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
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 at least 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 at Least 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.
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