Overview

Menthol for PDT Pain Relief

Status:
Completed
Trial end date:
2019-10-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Dundee
Treatments:
Menthol
Criteria
Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following
criteria apply:

1. Adults >18 years. Target population is men or women ≥50 years (only post-menopausal
women)

2. Presence of actinic keratoses (AK) on the face and scalp involving both right and left
comparable sites.

3. Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential
treatment area that may cause difficulty with examination or final evaluation.

4. Able to understand and adhere to protocol requirements.

Exclusion Criteria:

1. Unable to give written informed consent.

2. Allergy to menthol, aqueous cream or excipients

3. Participation in a drug trial or other interventional study within 30 days of
recruitment to this study

4. Pre-menopausal women, pregnancy, breast feeding, planning to conceive

5. Chronic pain