Drug penetration through skin and basal cell carcinoma
Research type
Research Study
Full title
Drug penetration through skin & basal cell carcinoma (BCC): Analysis by Time of flight-Secondary Ion Mass Spectroscopy (TOF-SIMS), 3D Hybrid-Secondary Ion Mass Spectrometry (Hybrid SIMS) and Confocal Raman Microscopy
IRAS ID
130880
Contact name
John Mckenna
Contact email
Sponsor organisation
University Hospital Leicester
Clinicaltrials.gov Identifier
113688, EDGE ID
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
Research Summary
This project aims to measure the penetration of drugs into healthy skin tissue and basal cell carcinoma (BCC) to aid the understanding of the effectiveness and safety of topical creams in treating basal cell carcinoma (particularly nodular BCC). This project will evaluate whether microneedles containing drug will enhance penetration into BCC tissues. The healthy skin control is used to assess the potential for unwanted absorption across the skin into the systemic circulation. In addition, this projects aims to identify any distinct chemical composition differences between healthy skin and BCC tissue using advanced analytical techniques. Any distinct differences discovered may help to explain any differences in permeation observed between BCC and healthy skin tissue. In addition, such differences discovered will aid the development of better formulation tailored to the nature of BCC tissue.
Summary of Results
In conclusion, the current work highlights that use of polymeric microneedles loaded with the anti-tumour drug, imiquimod were capable of breaching the tumour down to the depth which nodular basal cell carcinoma (BCC) typically resides. Permeation studies utilising Franz diffusion cells demonstrated that the polymeric microneedles were capable of delivering similar amount of the drug into the tumour relative to the commercial cream AldaraTM. This was achieved despite a 3-fold lower drug loading, relative to the current clinical dose of AldaraTM cream used in BCC treatment. In addition, ToF-SIMS analysis of ex vivo human BCC tumour cross-sections highlighted the presence of embedded drug-polymer matrix within tumour, which retains the drug within the tumour while reducing the permeation of the drug across the skin. In summary, this work suggests that the drug loaded polymeric microneedles developed in this work may be of clinical utility for localised intradermal delivery of imiquimod. Such formulations may provide a less invasive intervention to patients who would prefer an alternative treatment to surgery for the treatment of nodular BCC.
Overall, the study partially achieved its objective as we managed to demonstrate that polymeric microneedles were capable of achieving a higher % of dose delivered into the BCC tumour via the use of an in vitro permeation study. The study did not manage to achieve its complete objective as we suffered difficulties in recruiting patients due to the Covid-19 pandemic. We can confirm that the data obtained from this study will be used for publication in an academic journal.REC name
East of Scotland Research Ethics Service REC 1
REC reference
19/ES/0108
Date of REC Opinion
14 Oct 2019
REC opinion
Further Information Favourable Opinion