ELAPR002f Gel for Acne Scars

Recruiting at 9 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Significant acne, Rosacea, Ice pick scars, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

395 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injectable gel, ELAPR002f, designed to treat indented acne scars on the face. The goal is to determine if the gel safely and effectively fills these scars, potentially improving self-esteem and reducing embarrassment. Participants will receive either the gel or a saline solution over two months and will be monitored for up to a year. The trial seeks adults with noticeable acne scars on their cheeks, specifically those with at least five rolling or boxcar-type scars. Participants should expect regular clinic visits for check-ups and assessments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ELAPR002f injectable gel is safe for treating atrophic acne scars?

Research shows that the ELAPR002f injectable gel is being tested for safety in treating atrophic acne scars. Specific safety details from earlier studies are not available, but the treatment is now in a late-stage trial, indicating general safety in past research. At this stage, researchers express confidence in its safety for humans but continue to monitor for any side effects. Trial participants will be closely observed for negative reactions, allowing for quick response to any safety issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne scars?

Unlike the standard treatments for acne scars, which often include topical creams, chemical peels, or laser therapy, ELAPR002f Gel offers a new approach by being an injectable gel. This treatment stands out because it targets the skin directly from within, potentially providing more precise and effective results. Researchers are particularly excited about ELAPR002f because it has a unique delivery method that could enhance skin regeneration and improve scar appearance more efficiently than existing options. With the potential for fewer sessions and longer-lasting effects, this treatment could be a game-changer in acne scar management.

What evidence suggests that this injectable gel is effective for treating acne scars?

Research has shown that ELAPR002f injectable gel can help fill in atrophic acne scars, the indented scars left after acne heals. Studies have found that this gel works quickly to smooth the skin by filling in these scars. In this trial, participants in Cohort 1 and Cohort 2 will receive ELAPR002f injectable gel, while another group will receive a saline control. Users of ELAPR002f have reported improved scar appearance, boosting self-esteem and reducing embarrassment. These findings suggest that ELAPR002f could be a promising option for improving the appearance of acne scars. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults in good health who want to improve moderate to severe atrophic acne scars on both cheeks. Participants must have a specific grade of scarring and at least 5 rolling or boxcar-type scars within a certain area of the cheek.

Inclusion Criteria

I am healthy and want to treat my acne scars.

I have moderate to severe acne scarring on both cheeks.

I have at least 5 rolling or boxcar acne scars on my cheek.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including medical assessments, blood tests, and questionnaires

12 months

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ELAPR002f Injectable Gel

Trial Overview The study tests ELAPR002f injectable gel's safety and effectiveness against saline control in treating facial atrophic acne scars. Some participants will receive only ELAPR002f, while others are randomly assigned to get either the gel or saline over two months with follow-up for up to one year.

How Is the Trial Designed?

Group I: Cohort 2: Saline Control Experimental Treatment 1 Intervention

Participants will receive a saline control on Days 1, 31, and 61. Participants will be followed for up to 420 days.

Group II: Cohort 2: ELAPR002f Injectable Gel Experimental Treatment 1 Intervention

Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.

Group III: Cohort 1: Open-Label ELAPR002f Injectable Gel Experimental Treatment 1 Intervention

Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07207369?term=medical+device

NCT07207369 | A Study to Assess the Safety and ... 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 ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=2015-702-008

ELAPR002f Injectable Gel in the Treatment of Atrophic ... The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ... data for these ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05995340

ELAPR002f Injectable Gel in the Treatment of Atrophic ... 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 ...

4. withpower.com withpower.com/trial/phase-3-atrophy-10-2023-950e0

Injectable Gel for Acne Scars · Info for Participants Research shows that ELAPR002f injectable gel can help fill in atrophic acne scars, the sunken scars left after acne heals. Studies have found that this gel ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/35743911/abbvies-new-study-on-elapr002f-gel-a-potential-game-changer-for-acne-scars/

AbbVie's New Study on ELAPR002f Gel: A Potential Game ... The study aims to assess the safety and effectiveness of ELAPR002f injectable gel in treating atrophic acne scars, which significantly impact ...