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