A clinical investigation focusing on the Decoria Essence hyaluronic acid (HA) filler for aesthetic lip correction is currently enrolling participants by invitation. Sponsored by Bohus Biotech AB in collaboration with Key2Compliance, this study aims to evaluate the safety and performance of the device in improving lip aesthetics, a significant area of interest within the field of medical devices.
The study may hold importance for regulatory teams monitoring device trials, clinical professionals interested in advancements for dermal filler technologies, and quality assurance teams ensuring compliance with evolving medical device standards. Detailed information about the trial is available on ClinicalTrials.gov.
What is the trial investigating?
This clinical investigation evaluates the safety, efficacy, and performance of Decoria Essence, a HA-filler designed specifically to improve lip aesthetics. The study focuses on individuals seeking aesthetic corrections to their lips in a controlled clinical setting. By studying the outcomes, the goal is to gather evidence supporting the regulatory approval of the device for this indication.
What is Decoria Essence?
Decoria Essence is a medical device manufactured by Bohus Biotech AB. It is a hyaluronic acid-based filler, commonly used in cosmetic dermatology. HA fillers are widely recognized for their effectiveness in restoring volume, contouring, and enhancing skin elasticity. Decoria Essence is currently undergoing clinical validation for its targeted use in lip aesthetic corrections.
Hyaluronic acid fillers work by attracting water molecules, providing hydration and volume at the injection site. These fillers are designed to be biocompatible, minimizing potential tissue irritation or adverse reactions when applied under proper clinical conditions.
Who are the sponsors?
This trial is backed by Bohus Biotech AB, a Swedish biopharmaceutical company specializing in the development and production of hyaluronic acid-based products. Additionally, Key2Compliance, a regulatory compliance and quality assurance provider, is collaborating to ensure the study meets stringent clinical and regulatory standards.
The combined expertise of these sponsors suggests rigorous oversight and adherence to international standards for medical device trials, including those outlined in the EU Medical Device Regulation (MDR).
Frequently Asked Questions
1. Who can participate in this trial?
As noted in the study’s announcement, participants are being enrolled by invitation, suggesting eligibility criteria to ensure a controlled and compliant investigation.
2. What regulations govern this trial?
The study must comply with the regulatory guidelines set forth for medical devices, such as ensuring patient safety and demonstrating clinical performance under the MDR Annex XIV framework.
3. Where can I find more information?
Detailed information can be accessed via the official ClinicalTrials.gov website.
4. How does Decoria Essence differ from other HA-fillers?
Although the trial will provide further insights, Decoria Essence is presented as a specialized filler for lip correction purposes, with potential advantages in biocompatibility and efficacy.
Key takeaways and next steps
The ongoing clinical trial of Decoria Essence highlights continued development in aesthetic medical devices and supports the push for evidence-based regulatory approvals. Teams involved in quality assurance and regulatory affairs should monitor updates from this study. It may also influence future device submissions for aesthetic indications under the MDR or FDA standards.
The trial’s findings will contribute to scientific literature and could potentially validate innovative approaches to HA-filler use.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Readers should consult official sources and legal experts for accurate guidance on medical device regulations.
Learn more
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07188818?term=medical+device