ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

NCT05995340 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: 2015-702-008CIV-23-03-042622
• Study Type: interventional
• Target: 157
• Locations: 2 countries
• Sites: 12

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.

Conditions

Atrophic Acne Scars

Keywords

Atrophic Acne Scars; ELAPR002f injectable gel

Outcome Measures

Primary Outcomes (10)

• Percentage of Participants Achieving "Responder" Status Based on the Allergan Acne Scar Improvement Scale (ASIS)

  A "responder" is a participant who achieves at least a 1-grade improvement on both cheeks 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.

  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, and urinalysis. 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 Outcomes (4)

• Change from Baseline on the Overall Score of ACNE-Q Acne Scars Scale

  Up to Day 420

• Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress Scale

  Up to Day 420

• Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale

  Up to Day 420

• Percentage of Participants Achieving "Responder" Status Based on the ASIS

  Up to Day 420

Study Arms (2)

Saline Active Control

OTHER

Participants will receive 3 treatments of Saline Active Control into the cheek area on each side of the face.

Other: Saline Active Control

ELAPR002f Injectable Gel

EXPERIMENTAL

Participants will receive 3 treatments of ELAPR002f injectable gel into the cheek area on each side of the face.

Device: ELAPR002f Injectable Gel

Interventions

ELAPR002f Injectable Gel DEVICE

Intradermal Injections

ELAPR002f Injectable Gel

Saline Active Control OTHER

Intradermal Injections

Saline Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (12)

Alberta DermaSurgery Centre /ID# 243168

Edmonton, Alberta, T6G 1C3, Canada

Location

Humphrey & Beleznay Cosmetic Dermatology /ID# 266634

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pacific Derm /ID# 227467

Vancouver, British Columbia, V6H 4E1, Canada

Location

Dermetics Cosmetic Dermatology /ID# 227469

Burlington, Ontario, L7N 3N2, Canada

Location

The Centre For Clinical Trials /ID# 233841

Oakville, Ontario, L6J 7W5, Canada

Location

The Center For Dermatology /ID# 227470

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Bertucci MedSpa Inc. /ID# 227468

Woodbridge, Ontario, L4L 8E2, Canada

Location

Hautok and Hautok-cosmetics /ID# 227474

Munich, Bavaria, 80333, Germany

Location

Dermatologie Mahlow /ID# 262566

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

Location

Rosenpark Research /ID# 227471

Darmstadt, Hesse, 64283, Germany

Location

MVZ Corius MediCorium GmbH /ID# 227475

Friedrichsdorf, Hesse, 61381, Germany

Location

Privatpraxis Dr. Hilton & Partner /ID# 227472

Düsseldorf, North Rhine-Westphalia, 40212, Germany

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 16, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DE (5); CA (7)