Dr. Korman Laboratories Ltd has announced a new clinical trial to assess the safety and performance of its hyaluronic acid filler product, featuring a 20 mg/mL concentration crosslinked with sodium hyaluronate and 0.3% lidocaine, targeted for lip augmentation procedures. Set to commence soon, the trial represents a significant step in advancing medical device solutions for cosmetic enhancement.
Sponsored collaboratively by Dr. Korman Laboratories Ltd. and CTC Clinical Trial Consultants AB, the study is not yet recruiting but marks a forward-looking effort in the regulatory evaluation of minimally invasive aesthetic technologies.
In this article:
- What are the details of the study?
- What is the device under investigation?
- Why does the study matter?
- Frequently Asked Questions
- Key takeaway
- Disclaimer
- Study Announcement Link
What are the details of the study?
The clinical trial, set to begin in late 2025, will evaluate the safety and performance of Dr. Korman Laboratories’ hyaluronic acid filler in individuals undergoing lip augmentation. The investigational product combines crosslinked sodium hyaluronate (20 mg/mL) and lidocaine (0.3%) to achieve cosmetic improvement while minimizing injection discomfort.
According to the ClinicalTrials.gov record, the trial is being conducted in partnership with CTC Clinical Trial Consultants AB and remains in a pre-recruitment phase. Interested parties should monitor the official page for updates regarding inclusion criteria, locations, and timelines.
What is the device under investigation?
The investigational device, described as a dermal filler, utilizes crosslinked sodium hyaluronate combined with lidocaine for enhanced patient comfort during procedures. Hyaluronic acid fillers are widely recognized for their ability to restore volume, reduce wrinkles, and enhance facial features, but this trial will focus on its application specifically for lip augmentation. The inclusion of lidocaine, a commonly used local anesthetic, aims to reduce pain associated with injections.
Manufacturer statements indicate the product’s unique formulation may offer improved handling and patient satisfaction compared to existing fillers on the market. However, the trial’s data is necessary to substantiate performance claims and regulatory compliance.
Why does the study matter?
This trial holds significance for regulatory, clinical, and quality assurance professionals. Under the MDR Annex XIV framework, clinical evidence is required to demonstrate both the safety and performance of medical devices for their intended purpose. The data generated from this study will help determine whether the product meets regulatory standards for safe use in cosmetic procedures.
Moreover, the growing demand for minimally invasive aesthetic treatments continues to push manufacturers toward innovations that address both effectiveness and patient comfort. Trials like this one are essential for maintaining public trust in cosmetic devices and ensuring compliant market entry.
Frequently Asked Questions
1. Who is eligible to participate in the study?
Eligibility criteria have not been released. More information will be available once recruitment begins.
2. When will the trial start recruiting?
The study is not yet recruiting as of October 2025. Updates can be found on ClinicalTrials.gov.
3. Where will the trial locations be?
Trial sites and geographic details are not yet disclosed but will be provided closer to recruitment phases.
Key takeaway
The upcoming clinical trial for Dr. Korman Laboratories’ hyaluronic acid filler is poised to contribute valuable data on safety and performance within the expanding domain of aesthetic medical devices. Professionals monitoring this space should expect further updates over the coming months.
Disclaimer
This article is intended for informational purposes and does not constitute regulatory, legal, or clinical advice. Readers should consult appropriate professionals for specific guidance related to medical devices or clinical trials.
Study Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07204691?term=medical+device