A study of menthol for pain relief during photodynamic therapy

  • Research type

    Research Study

  • Full title

    A randomised double blind, placebo controlled study of the efficacy of topical menthol for pain relief during topical photodynamic therapy.

  • IRAS ID

    194809

  • Contact name

    Sally Ibbotson

  • Contact email

    s.h.ibbotson@dundee.ac.uk

  • Sponsor organisation

    University of Dundee

  • Eudract number

    2015-002849-59

  • Duration of Study in the UK

    1 years, 3 months, days

  • Research summary

    Skin cancer and sun-induced skin damage have dramatically increased in incidence. Photodynamic therapy (PDT) involves light activation of a chemical which is light sensitive (photosensitiser) and localised in the diseased skin and this is widely used to treat these conditions. Whilst PDT is effective, a major limitation is pain during light treatment, which can be severe. Neither photosensitiser nor irradiation alone cause pain. Topical local anaesthetics and analgesics are ineffective and the mechanisms of PDT-induced pain are unknown, hampering the development of alternative treatments. We have undertaken pre-clinical studies, which have identified menthol as a possible way to prevent or relieve PDT-pain. In this proposal we will investigate in humans, the use of menthol for pain relief during PDT. We will undertake a randomised double blind placebo-controlled study in patients receiving PDT for actinic keratosis (sun damage)on the face and scalp. Based on our pre-clinical studies, we expect that menthol will alleviate pain. If so this will likely have considerable impact, through its routine incorporation into treatment regimes, markedly improving the patient experience and the efficiency of PDT, resulting in improved patient care.

  • REC name

    East of Scotland Research Ethics Service REC 2

  • REC reference

    16/ES/0127

  • Date of REC Opinion

    9 Nov 2016

  • REC opinion

    Further Information Favourable Opinion