Dermatological ex-vivo skin research investigations
Research type
Research Study
Full title
Assessment of ex-vivo skin hydration, penetration and barrier behaviour following application of novel and commercially available topical formulations.
IRAS ID
315372
Contact name
Milan Antonijevic
Contact email
Sponsor organisation
University of Greenwich
Duration of Study in the UK
1 years, 7 months, 27 days
Research summary
This study involves working with retrospectively collected ex-vivo (i.e., removed from the body) human skin samples. No prospective recruitment or sample collection will take place. Only skin samples from the UK and French tissue banks with all relevant approvals will be used. Samples will primarily be sought from UK tissue banks; French tissue banks will be utilised if the UK banks are not in a position to supply the skin samples of the required size and quality.
A template for donor consent will be requested from each prospective tissue bank. Skin samples that are transferred from a tissue bank will arrive at the University of Greenwich fully anonymised (no personal data will be transferred with the samples).
The University of Greenwich will use appropriate procedures and scientific rigour to ensure the skin samples are stored, used and disposed of safely, and will pay due regard to the ethical obligations and responsibilities associated with performing tests on donated human tissue in accordance with the Human Tissue Act 2004.
All the medicinal substances involved in the proposed testing will be well-established drug substances that are widely used, mainly in oral and topical dosage forms (i.e., tablets, creams, gels). None will be a new chemical entity or a controlled drug.
All laboratory techniques and methods utilised will be designed and developed to be reliable methods for screening numerous formulations and predicting the performance in-vivo (i.e., human skin on a living person, not a skin sample) before the best candidates are taken for further testing, such as user evaluations or clinical testing involving human participants. This removes any need to conduct this early testing directly with human volunteers, where ethical issues would arise.
As no genetic testing is going to be performed, no patient-related information (e.g., sex, age) could be established from the above-mentioned techniques.
A range of Standard Operating Procedures (SOPs), risk assessments, and Control of Substances Hazardous to Health (COSHH) forms are in place covering all aspects of the work.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0240
Date of REC Opinion
31 Oct 2022
REC opinion
Further Information Favourable Opinion