Menthol for PDT Pain Relief

Actinic Keratosis Clinical Trial

— MentholPDT  

Official title:

A Randomised Double Blind, Placebo Controlled Study of the Efficacy of Topical Menthol for Pain Relief During Topical Photodynamic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984072
• Other study ID #: 2015PQ01
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: March 2021
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Menthol
Topical menthol in aqueous cream
• Aqueous Cream
placebo

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital and medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blinding - patient will be asked which side they think the menthol was used on or if they do not know	patient questionnaire completed at home and returned in SAE	24h
Primary	Pain immediately after PDT assessed by VAS score	pain immediately after and at 3, 6 and 24 h after PDT assessed by VAS score	24h
Secondary	Clearance: clear/partially clear/not clear - clinical assessment visually and by palpation	Clearance (CR), partial clearance (PR) or no clearance (NR) will be recorded on each side in each participant	3 months after treatment
Secondary	Erythema (redness) (none/mild/moderate/severe)	Erythema grading (none/mild/moderate/severe) will be recorded on each side in each participant	Immediately after PDT
Secondary	fluorescence assessed as none/mild/moderate/strong using Wood's light examination	Fluorescence of each side in each participant will be recorded	Immediately before and after PDT
Secondary	patient preference - preferred right or left side or no preference	patient questionnaire completed at home and returned in SAE	24h
Secondary	swelling	Swelling present or absent will be recorded on each side in each patient	immediately after PDT
Secondary	Exudation	Exudation present or absent will be recorded on each side in each patient	immediately after PDT
Secondary	urticaria	Urticaria present or absent will be recorded on each side in each patient	immediately after PDT