ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Atrophic Acne Scars
• Intervention / Treatment: Device: ELAPR002f Injectable Gel; Other: Saline Control

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Recruiting
      • Alberta DermaSurgery Centre /ID# 243168
      • Contact: Site Coordinator; Phone Number: (780) 437-7189
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 4E1
      • Recruiting
      • Pacific Derm /ID# 227467
      • Contact: Site Coordinator; Phone Number: 604 682 7577
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Recruiting
      • Humphrey & Beleznay Cosmetic Dermatology /ID# 266634
      • Contact: Site Coordinator; Phone Number: (604) 616 6619
  • Ontario
    • Burlington, Ontario, Canada, L7N 3N2
      • Recruiting
      • Dermetics Cosmetic Dermatology /ID# 227469
      • Contact: Site Coordinator; Phone Number: 1-905-336-9624
    • Oakville, Ontario, Canada, L6J 7W5
      • Recruiting
      • The Centre for Clinical Trials /ID# 233841
      • Contact: Site Coordinator; Phone Number: 1-905-842-2262
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • Recruiting
      • The Center For Dermatology /ID# 227470
      • Contact: Site Coordinator; Phone Number: +1-905-889-2019
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Recruiting
      • Bertucci MedSpa Inc. /ID# 227468
      • Contact: Site Coordinator; Phone Number: 905 -850-4415
• Germany
  • Muenchen, Germany, 80333
    • Recruiting
    • Hautok and Hautok-cosmetics /ID# 227474
  • Oberursel, Germany, 61440
    • Recruiting
    • MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 227475
    • Contact: Site Coordinator; Phone Number: +49 6172 17 17 20
  • Brandenburg
    • Blankenfelde-Mahlow, Brandenburg, Germany, 15831
      • Recruiting
      • Dermatologische Gemeinschaftspraxis Mahlow /ID# 262566
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Recruiting
      • Rosenpark Research /ID# 227471
      • Contact: Site Coordinator; Phone Number: +49 (6151) 627 070
  • Nordrhein-Westfalen
    • Duesseldorf, Nordrhein-Westfalen, Germany, 40212
      • Recruiting
      • Privatpraxis Dr. Hilton & Partner /ID# 227472
      • Contact: Site Coordinator; Phone Number: +49 (0)21186292890

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): August 18, 2025
• Study Completion (Estimated): August 18, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Atrophic Acne Scars; ELAPR002f injectable gel
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 2015-702-008; CIV-23-03-042622 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes