Clinical trial NCT05995340: ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atrophic Acne Scars
Keywords: Atrophic Acne Scars
ELAPR002f injectable gel
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 clinically significant acne 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 lung disease.
* Known hypersensitivity to the constituents of the device.
* Visual acuity of 20/100 or worse or abnormal confrontational visual fields or ocular motility.

Primary outcomes:
measure: Percent Change from Baseline in Acne Scar Area
timeFrame: Baseline to Day 181
measure: Number of Participants with Adverse Events
timeFrame: Up to Day 420
measure: Number of Participants with Presence of Binding Antibodies
timeFrame: Up to Day 420
measure: Number of Participants with Injection Site Responses (ISRs) and Systemic Responses
timeFrame: Up to Day 420
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
timeFrame: Up to Day 420
measure: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
timeFrame: Up to Day 420
measure: Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements
timeFrame: Up to Day 420
measure: Change from Baseline Procedure Pain
timeFrame: Up to Day 61
measure: Number of Participants with a Positive Skin Test
timeFrame: Up to Day 30
measure: Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion
timeFrame: Up to Day 420
Secondary outcomes:
measure: Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire
timeFrame: Up to Day 420
measure: Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress
timeFrame: Up to Day 420
measure: Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin
timeFrame: Up to Day 420
measure: Percentage of Participants Achieving "Responder" Status on Either Cheek Based on the Allergan Acne Scar Improvement Scale (ASIS), as assessed by the Evaluating Investigator
timeFrame: Up to Day 420
measure: Percentage of Participants who Achieve at Least a 20% Reduction in Acne Scar Area
timeFrame: Up to Day 420
measure: Percent Change from Baseline in Acne Scar Area
timeFrame: Up to Day 420
measure: Percent Change from Baseline in Acne Scar Volume
timeFrame: Up to Day 420
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre /ID# 243168
state: Alberta
city: Vancouver
country: Canada
facility: Humphrey & Beleznay Cosmetic Dermatology /ID# 266634
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm /ID# 227467
state: British Columbia
city: Burlington
country: Canada
facility: Dermetics Cosmetic Dermatology /ID# 227469
state: Ontario
city: Oakville
country: Canada
facility: The Centre For Clinical Trials /ID# 233841
state: Ontario
city: Richmond Hill
country: Canada
facility: The Center For Dermatology /ID# 227470
state: Ontario
city: Woodbridge
country: Canada
facility: Bertucci MedSpa Inc. /ID# 227468
state: Ontario
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics /ID# 227474
state: Bayern
city: Blankenfelde-Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 262566
state: Brandenburg
city: Darmstadt
country: Germany
facility: Rosenpark Research /ID# 227471
state: Hessen
city: Oberursel
country: Germany
facility: MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 227475
state: Hessen
city: Duesseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner /ID# 227472
state: Nordrhein-Westfalen
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: