New Clinical Trial to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel for Acne Scars

A new clinical trial aims to assess the safety and effectiveness of ELAPR002f Injectable Gel for treating atrophic acne scars. The trial, sponsored by AbbVie, is slated to begin recruitment soon and invites adult participants with atrophic acne scars. This announcement serves as a critical update for clinicians, regulatory experts, and quality teams monitoring advancements in dermatological treatments.

Published: October 7, 2025

In this article:

What is the purpose of this clinical trial?

The trial will investigate the use of a novel injectable gel, ELAPR002f, for addressing atrophic acne scars in adults. Atrophic scars are among the most challenging acne-related conditions to manage, marked by a loss of skin tissue resulting in depressions or pitted areas. This study focuses on exploring the therapeutic potential of the device and comparing its outcomes against a saline control group.

Treatments combining safety, aesthetics, and user accessibility have seen increasing demand in recent years. This context establishes the significant clinical and regulatory interest in this trial.

How will safety and effectiveness be evaluated?

Key outcomes for the trial will include safety and efficacy evaluations. Safety metrics aim to identify any adverse reactions or complications resulting from the gel’s use. Effectiveness will likely be assessed through clinical improvement in the appearance and texture of atrophic acne scars.

Participants will experience randomized assignment to either the investigative ELAPR002f gel or saline control group. This controlled design will ensure meaningful comparisons of efficacy and minimize bias in the results. Such rigor aligns with best practices under ISO and MDR clinical evaluation frameworks.

Who is running the trial and what happens next?

The trial is sponsored by AbbVie, a major pharmaceutical and medical device manufacturer recognized for products spanning dermatology and aesthetics. With extensive resources and domain expertise, the company’s sponsorship ensures high-quality implementation under ethical and regulatory standards.

As of now, recruitment for participants has not begun. Clinicians and stakeholders can follow updates on ClinicalTrials.gov or register interest to engage directly as investigators or facilitators. Regulatory submission plans for this device will depend on trial outcomes, aligning with MDR and FDA pathways.

Frequently Asked Questions

  1. What is ELAPR002f?
    ELAPR002f is an investigational injectable gel developed to treat atrophic scars caused by acne.
  2. Who can participate in this trial?
    Adults with atrophic acne scars meeting inclusion criteria may enroll.
  3. When does enrollment begin?
    Enrollment is currently listed as “Not yet recruiting” according to ClinicalTrials.gov.
  4. How can I find more information?
    Details are available on ClinicalTrials.gov. The reference link is provided below.

Conclusion

This clinical trial represents a significant research opportunity in dermatological treatments, addressing an unmet need for advanced acne scar management. Stakeholders in clinical research and regulatory domains should monitor developments closely to understand its implications for future approvals and market access pathways.

Disclaimer

This article is intended for informational purposes only. It does not constitute medical, regulatory, or legal advice. Always consult the trial sponsor and official guidelines.

Source Information

For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07207369?term=medical+device