A new clinical trial aimed at assessing the performance and safety of the INNEA and INNEA AQUA medical devices has opened recruitment. The study focuses on their potential efficacy in addressing wrinkles in the cheeks and décolletage areas, targeting signs of aging that concern many worldwide. Regulatory, clinical, and quality control stakeholders invested in dermatological device innovation may find this trial particularly noteworthy.
Sponsored by Innate srl, in collaboration with 1Med, this clinical investigation seeks to objectively evaluate these solutions under controlled conditions. Interested professionals can access more information via the ClinicalTrials.gov link provided below.
In this article
- What is the purpose of the trial?
- What are INNEA and INNEA AQUA?
- How is the study designed?
- FAQ
- Key takeaways
- Disclaimer
- Full information link
What is the purpose of the trial?
The primary objective of this trial is to evaluate the ability of INNEA and INNEA AQUA to reduce the appearance of wrinkles in the cheek and décolletage areas. Additionally, the researchers aim to ensure the safety of these devices for users, consistent with medical device regulations regarding clinical investigations.
Why focus on the cheeks and décolletage?
Wrinkles in these areas often mark early visible aging signs and present aesthetic challenges for patients. As such, the outcomes may hold significant implications for cosmetic dermatology and anti-aging treatments.
What are INNEA and INNEA AQUA?
INNEA and INNEA AQUA are medical devices designed for dermatological applications, specifically targeting skin rejuvenation and wrinkle reduction. Further details regarding their composition and proprietary technologies are expected to emerge as part of this study’s findings.
Device classification and compliance
Both products are classified as medical devices. They must comply with internationally recognized standards, ensuring safety and performance before widespread adoption in cosmetic treatments.
How is the study designed?
The trial follows key Good Clinical Practice (GCP) principles, ensuring data integrity and participant safety throughout the investigation. Patients are now being recruited for participation.
Who can participate?
The trial targets individuals seeking treatment for wrinkles in specific areas. Eligibility criteria, including age and general skin health, will determine suitable candidates.
What are the expected outcomes?
- Reduction in wrinkles, as assessed using validated clinical measures.
- Confirmation of device safety through documented absence of adverse events.
FAQ
- When does recruitment end?
Recruitment is currently open. Interested participants should inquire promptly for enrollment details. - Where can professionals monitor progress?
Regular updates about the study will be available via ClinicalTrials.gov. - Are results expected soon?
Clinical trials of this nature usually take several months to complete, followed by data analysis.
Key takeaways
This study represents a significant opportunity to determine the potential of INNEA and INNEA AQUA medical devices in the field of wrinkle treatment. By emphasizing safety and efficacy, the sponsors aim to validate these products’ roles in aesthetic medicine. Regulatory and clinical teams should monitor developments closely as the trial progresses.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Healthcare professionals should consult authoritative sources for compliance specifics.
Full information link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07331181?term=medical+device