What is the mechanism of action of this treatment?

The most common treatments for atrophic acne scars, such as injectable fillers like hyaluronic acid, work by providing an immediate space-occupying effect that fills in the indented scar tissue, creating a smoother skin surface. This volumizing effect elevates the depressed areas, making the scars less noticeable. Some fillers also stimulate collagen production, which can improve skin texture and elasticity over time. These mechanisms are important for atrophic acne scar patients as they offer both immediate and long-term improvements in skin appearance, enhancing self-esteem and quality of life.

What side effects are associated with this type of intervention?

Injectable treatments for atrophic acne scars, such as hyaluronic acid fillers, poly-L-lactic acid, calcium hydroxylapatite, and PMMA microspheres, commonly cause side effects like bruising, swelling, redness, and discomfort at the injection site. Less common but more serious complications include nodule formation, granulomatous reactions, and vascular issues like skin necrosis or embolism. Ensuring proper injection technique and clinician expertise is essential to minimize these risks.

What prior FDA approvals exist?

Several injectable fillers have received FDA approval for the treatment of atrophic acne scars, focusing on their ability to provide immediate volume and stimulate collagen production. Polymethylmethacrylate (PMMA) microspheres, found in products like Bellafill, are approved for this purpose and work by filling soft tissue and promoting new collagen formation. Hyaluronic acid fillers, such as Juvéderm and Restylane, are also commonly used for their immediate filling effect and have been approved for various facial augmentations, including acne scars. These treatments are similar to the investigational ELAPR002f Injectable Gel, which aims to fill scar tissue and improve skin appearance.

What other types of research exist?

Promising alternatives to ELAPR002f Injectable Gel for atrophic acne scars include: 1) Hyaluronic acid fillers, which provide immediate volume and stimulate collagen production. 2) Calcium hydroxylapatite fillers, known for their longevity and collagen-stimulating properties. 3) Poly-L-lactic acid fillers, which gradually stimulate collagen production for long-term improvement. 4) Polymethylmethacrylate microspheres, which offer a permanent solution by stimulating new collagen formation. These alternatives have shown efficacy in clinical trials and are widely used for soft tissue augmentation.

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Injectable Gel

Injectable Gel for Acne Scars

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 420

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new gel called ELAPR002f to help fill in and smooth out indented acne scars on the face. It targets adults with noticeable acne scars who haven't had success with other treatments. The gel works by filling in the scarred areas to make the skin look smoother. Participants will receive multiple treatments and be monitored for an extended period.

Who is the study for?

This trial is for adults in good health who want to improve moderate to severe atrophic acne scars on both cheeks. They must not have an active COVID-19 infection and should have at least 5 rolling or boxcar-type scars in areas of otherwise healthy skin.

What is being tested?

The study compares the safety and effectiveness of ELAPR002f injectable gel versus a saline control in treating facial atrophic acne scars. Participants will be randomly assigned to one of these treatments, with a higher chance of receiving the gel.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as redness, swelling, pain, bruising, bleeding or itching. There might also be general discomfort associated with intradermal injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 420

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 420

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 420 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Procedure Pain

Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements

+6 more

Secondary study objectives

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

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

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

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Saline Active ControlExperimental Treatment1 Intervention

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

Group II: ELAPR002f Injectable GelExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for atrophic acne scars, such as injectable fillers like hyaluronic acid, work by providing an immediate space-occupying effect that fills in the indented scar tissue, creating a smoother skin surface. This volumizing effect elevates the depressed areas, making the scars less noticeable. Some fillers also stimulate collagen production, which can improve skin texture and elasticity over time. These mechanisms are important for atrophic acne scar patients as they offer both immediate and long-term improvements in skin appearance, enhancing self-esteem and quality of life.

Resistance of rapidly expanded random skin flaps to bacterial invasion.A Double-Blind, Randomized Trial Shows the Role of Zonal Priming and Direct Topical Application of Epigallocatechin-3-Gallate in the Modulation of Cutaneous Scarring in Human Skin.Effect of P144® (Anti-TGF-β) in an "In Vivo" Human Hypertrophic Scar Model in Nude Mice.