Pilot investigating pharmacokinetics of isotretinoin (ISO) in acne
Research type
Research Study
Full title
A pilot study to explore the pharmacokinetics of ISO and gene expression changes in the blood and skin in patients with acne
IRAS ID
343548
Contact name
Alison Layton
Contact email
Sponsor organisation
University of York
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Acne is one of the common inflammatory skin problems worldwide and affects up to 5 million people in the UK. ISO is prescribed for those who have severe acne, acne resistant to other treatments and acne at risk of scarring. Whilst ISO is an extremely effective treatment for acne, there can be undesirable side effects and we don’t fully understand how it works in the body. Absorption of ISO is much better when taken with a fatty meal but higher ISO levels may be associated with more side effects. A large study to assess the benefits and harms of taking a low or a high dose of ISO, has been funded by the NIHR (Award ID:151318) but falls short of providing details of how ISO exactly works. This pilot study will explore the relationship between concentrations of ISO in the skin and blood and also explore if there are any genetic changes seen in skin samples when taking ISO. This will help us to better interpret the results of the larger study mentioned above. This will ultimately inform how we can best prescribe ISO for patients taking it for their acne to maximise effectiveness and minimise the side effects.
Twenty patients will be recruited from a single hospital site, who are 16 years and older, both male and female and who have been taking ISO as a first course for a minimum of 8 weeks (to ensure steady state of medication) as part of their standard care, will be approached to take part in this pilot study. They will have received information on this study at a prior visit. Informed, signed consent will be taken. Samples taken per patient, at one site visit, will include:
(i)a 5ml plasma blood sample taken at the same time as usual monitoring bloods taken as part of standard care,
(ii) a 6mm punch skin biopsy from a) clinically normal and b) an acne spot. We will avoid cosmetically sensitive sites and agree the anatomical location on the day with the patient.
Samples will be analysed by a team at the University of York with some samples, sent for further analyses at the CAMS institute, University of Oxford.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
24/WM/0263
Date of REC Opinion
16 Jan 2025
REC opinion
Further Information Favourable Opinion