drugset / Trial / NCT02984072

Menthol for PDT Pain Relief

NCT02984072

Phase 4 Completed 10 enrolled University of Dundee
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Topical photodynamic therapy (PDT) is widely used to treat superficial non-melanoma skin cancer (NMSC) and dysplasia, notably actinic keratosis and may also be effective in a range of other dermatological conditions. A major limitation of PDT is pain during irradiation. A lack of knowledge of the mechanism of PDT-induced pain has limited the development of effective approaches for prevention or relief of this adverse effect. The investigators have investigated the possible efficacy of menthol for PDT pain ex vivo and will now study this in a clinical trial. This proposal describes the prospective randomised double blind, placebo controlled clinical trial that will be undertaken to investigate the use of topical menthol for PDT-induced pain relief in patients with actinic keratosis of the face and scalp who will be attending general dermatology and PDT outpatient clinics at Ninewells Hospital, Dundee.

Timeline

Start
2018-10-23
Primary completion
2019-10-10
Completion
2019-10-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Menthol Small molecule 5 % Topical

Indications