Safety and Performance of PTMC Dermal Filler
Research type
Research Study
Full title
A Prospective, Multi-Centre, Single-Arm First-In-Man Study to Evaluate the Safety and Performance of PTMC Dermal Filler for the Correction of Moderate to Severe Nasolabial Folds
IRAS ID
329257
Contact name
Martyn King
Contact email
Sponsor organisation
AQPHA Medical B.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
The PTMC Dermal Filler Study is a multicenter, prospective, single-arm, first-in-human clinical investigation involving a new dermal filler developed by AQPHA™ Medical B.V., The Netherlands. The product, known as PTMC Dermal Filler, is designed for the correction of moderate to severe nasolabial folds in adult males and females. The study will be conducted at up to 6 sites in the United Kingdom and France.
PTMC, the key ingredient of the dermal filler, is a well-known soft medical polymer that has been used successfully in numerous CE-marked and FDA-approved bioresorbable product applications worldwide for several decades, demonstrating an excellent safety profile.
The objective of this investigation is to demonstrate the clinical safety and performance of the PTMC Dermal Filler for the correction of moderate to severe nasolabial folds up to 18 months following treatment. Data from this clinical investigation will be used to support a CE/UKCA marking application for PTMC Dermal Filler.
This investigation will enroll 120 healthy subjects and will be divided into 2 stages. In the safety run-in (Stage I), a small cohort of subjects will receive treatment with PTMC Dermal Filler to assess initial safety. A maximum of 15 subjects will be enrolled, after which enrollment will be temporarily paused. Throughout the safety run-in period, a data monitoring committee (DMC) will monitor all emerging safety issues. A formal review of initial safety will be conducted by the DMC once all subjects in the safety cohort have reached 4 weeks after initial treatment.
The re-opening of enrollment will only occur upon authorization from the DMC to proceed. Safety run-in subjects will be followed for 18 months, similar to Stage II subjects. Stage II of the clinical investigation will evaluate the safety and performance of PTMC Dermal Filler and will continue until all 120 subjects have been enrolled.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0107
Date of REC Opinion
3 Jan 2025
REC opinion
Further Information Favourable Opinion