Prospective Non Interventional Study Evaluates Periorbital Rejuvenation Regimen Using Letybo and Philart Eye Devices

Meta description: This report covers a prospective non interventional study of a periorbital rejuvenation regimen using Letybo and two devices. Sponsors are Yuvell and Croma Pharma GmbH and the record shows an active not recruiting status. The ClinicalTrials.gov entry number is NCT07398755 and the posting date context is February 11 2026.

In this article we summarize the key facts from the ClinicalTrials.gov record and discuss potential regulatory implications for medical devices and a drug under a real world observational framework.

What is being studied?

The listing identifies a prospective non interventional study focusing on a periorbital rejuvenation approach. The listed interventions include a drug named Letybo and two devices named Philart Eye and Saypha Volume Plus Lidocaine. The conditions named in the record are glabellar lines midface volume deficiency and periorbital wrinkling. The aim is to observe real world use and safety aspects of these interventions as part of an observational data collection in routine clinical settings.

  • Drug: Letybo
  • Device: Philart Eye
  • Device: Saypha Volume Plus Lidocaine

Sponsors listed are Yuvell and Croma Pharma GmbH. The record shows status as active not recruiting and provides the trial number NCT07398755 along with a direct reference to the ClinicalTrials.gov listing for traceability and further details.

The entry uses neutral registry language and does not specify endpoints or a formal sample size in this listing. Observers should monitor for updates that may include additional protocol details or outcome measures as the study progresses.

What conditions are addressed?

Glabellar lines midface volume deficiency and periorbital wrinkling are the named conditions in the record. These signs are commonly observed in facial aging and often drive the selection of rejuvenation strategies. The listing does not provide efficacy outcomes at this stage but frames the study as observational data collection aimed at safety and real world performance signals.

What is the study design?

The document describes a prospective non interventional study. It does not indicate randomization or a control group in this listing. The design is described as observational with the goal of gathering information on how the listed interventions are used in regular clinical practice and what safety signals may emerge from such use.

What is the regulatory context and who oversees the study?

The trial is listed with two sponsors named Yuvell and Croma Pharma GmbH. The interventions include a drug and two devices. The status is active not recruiting which indicates the study is ongoing under an observational framework within the regulatory structures that govern post market and observational data collection. The NCT number provided offers traceability to the ClinicalTrials.gov page which contains the official registry details and any updates.

What this means for practice and device development?

For clinicians the record signals an observational context for the named interventions that may inform consent discussions and monitoring during real world use. For device developers and sponsors the listing demonstrates adherence to regulatory expectations for post market surveillance and observational data collection for both a device and a drug in a combined regimen. Because the entry does not present efficacy claims at this stage clinicians should await final results and any regulatory disclosures before applying conclusions to practice.

FAQ

  1. 1. What is this study about This entry describes a prospective non interventional evaluation of a periorbital rejuvenation regimen using Letybo and two devices.
  2. 2. Who sponsors the study Yuvell and Croma Pharma GmbH are listed as sponsors.
  3. 3. Where can the record be found The ClinicalTrials.gov listing for NCT07398755 is provided.

Conclusion

In summary this entry documents a prospective non interventional study of a periorbital rejuvenation regimen using Letybo and Philart Eye and Saypha Volume Plus Lidocaine. The record shows active not recruiting and provides the NCT number for reference. Stakeholders should monitor the ClinicalTrials.gov listing for updates and any regulatory disclosures. Observational data may inform future safety and performance discussions while final results are pending.

Disclaimer

This information is intended for professionals and is not legal advice. It does not replace regulatory counsel or formal guidance for trial conduct.

For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07398755?term=medical+device

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