Menthol for PDT Pain Relief

NCT ID: NCT02984072

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2019-10-10

Brief 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.

Detailed Description

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.

This will be undertaken by comparison of 5% menthol in aqueous cream with aqueous cream as placebo and the primary outcome measures will be pain recorded on a visual analogue scale (VAS) during and up to 24 h after PDT. Secondary outcomes are phototoxicity, assessed by a semi-quantitative scoring system immediately after PDT, fluorescence assessed routinely after cream application and before irradiation and outcome based on clinical assessment three months after PDT and patient evaluation. Patients will be involved in the study from the first visit for PDT until the three-month assessment visit after PDT. Data analysis will be undertaken using within-subject paired analyses as patients act as their own control. Information from this study will inform investigators as to whether topical menthol should be routinely incorporated into PDT treatment regimens in order to reduce pain and increase tolerance of treatment. The information will also provide additional information as to the mechanisms of PDT-induced pain and its possible prevention and/or relief.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Menthol

5% menthol in aqueous cream (Dermacool Forte)

Group Type: ACTIVE_COMPARATOR

Menthol

Intervention Type: DRUG

Topical menthol in aqueous cream

Placebo

Aqueous cream

Group Type: PLACEBO_COMPARATOR

Aqueous Cream

Intervention Type: DRUG

placebo

Interventions

Menthol

Topical menthol in aqueous cream

Intervention Type: DRUG

Aqueous Cream

placebo

Intervention Type: DRUG

Other Intervention Names

5% menthol in aqueous cream; placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally H Ibbotson, MBChB, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Ninewells Hospital and medical School

Dundee, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015PQ01

Identifier Type: -

Identifier Source: org_study_id