Acne treatment by photodynamic therapy. Version 1
Research type
Research Study
Full title
Open-label, within-subject controlled, Phase IIa study to investigate repeat dose antimicrobial photodynamic therapy in patients with acne vulgaris.
IRAS ID
44294
Contact name
Alison Layton
Sponsor organisation
Photopharmica
Eudract number
2010-018313-29
ISRCTN Number
Not available
Research summary
Acne is a very common disease affecting 80% of adolescents. Approximately 3.5 million GP consultations for acne occur in the UK each year. Current treatments applied to the skin are not sufficiently effective in the treatment of acne. High levels of bacteria (Propionibacterium acnes- P.acnes) are implicated in the origin and development of the disease. Topical and oral antibiotics are common treatments used for mild to moderate acne but there are growing concerns about their long-term use due to the emergence of antibiotic resistant strains which may result in reduced or no response to antibiotic in acne sufferers. Alternative oral therapies including hormonal therapy for women and isotretinoin for both sexes are not without potential serious effects, including increased risk of blood clots with oral contraceptives and severe disabilites to a foetus and possible psychological problems associated with oral isotretinoin. There is therefore an unmet medical need to develop a novel treatment to eradicate bacteria (P.acnes) in acne. This new method (known as photodynamic therapy, PDT) involves putting a special gel on the affected area and shining visible red light onto this area for a short period of time, around 8 minutes. The gel contains a special drug and the light activates the drug to kill the bacteria. The gel and light will be applied to a small area of non exposed skin on the subjects back at two weekly intervals over a 6 week period to give four doses in total and this will be compared to only shining light onto an adjacent but similar small area on the back at the same visit to the clinic. 10 subjects with moderate acne will be asked to take part in this study at Harrogate and District Trust Hospital. The research is funded by Photopharmica Ltd. ;
REC name
North East - York Research Ethics Committee
REC reference
10/H0903/9
Date of REC Opinion
19 Mar 2010
REC opinion
Favourable Opinion