CPH-101-201395
Research type
Research Study
Full title
A prospective, multicenter clinical investigation to evaluate the safety and effectiveness of THIODERM EYES in reducing a moderate to severe volume deficit of infraorbital hollows
IRAS ID
263085
Contact name
Roshan Ravindran
Contact email
Sponsor organisation
CROMA PHARMA GmbH
Clinicaltrials.gov Identifier
tbd (registered after approval by CA), Eudamed Number
Duration of Study in the UK
1 years, 2 months, 20 days
Research summary
In this prospective, open-label, non-comparative multicenter clinical study the safety and effectiveness of THIODERM EYES for reducing moderate to severe volume deficit of infraorbital hollows (IOH) shall be evaluated.
Volume deficit of IOH causes an exhausted and unhealthy appearance, that may be experienced as distressing and socially inhibiting by affected persons.
Aesthetic corrections of such blemishes, e.g. by means of dermal fillers, can therefore significantly improve the well-being of people who elect to undergo such procedures.The investigational medical device (IMD), THIODERM EYES, is a novel hyaluronic-acid (HA) based dermal filler. The HA molecules of this filler have been crosslinked via disulfide bond formation between previously enriched native thiolated HA chains. By this novel method of crosslinking the use of Butanediol-diglycidyl-ether (BDDE), a crosslinking agent of widespread use, whose potential genotoxicity necessitates elaborate and expensive purification and analysis procedures,is avoided.
The study is divided into two parts.
In part 1, 10 patients will receive 3 successive injections of escalating doses (volumes) of the IMD into the dermis or subcutis of the inner aspect of the upper arm. To ensure safety of the participants, there will be observational periods between individual injections and between administration of the IMD to different participants. Safety and local tolerability will be asessed.After collection of safety data from all participants in part 1, a safety data review meeting will take place to decide whether or not to proceed to part 2 of the study.
In part 2, 75 patients with volume deficit of infraorbital hollows will be treated with the IMD. In addition to the assessment of safety and tolerability, the success of the treatment will be evaluated by the patients, investigators and by an independent assessor of photographs, taken throughout the study.
REC name
HSC REC B
REC reference
19/NI/0116
Date of REC Opinion
14 Jun 2019
REC opinion
Unfavourable Opinion