Clinical trial NCT02984072: Menthol for PDT Pain Relief
Official title: A Randomised Double Blind, Placebo Controlled Study of the Efficacy of Topical Menthol for Pain Relief During Topical Photodynamic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain immediately after PDT assessed by VAS score
timeFrame: 24h
Secondary outcomes:
measure: Clearance: clear/partially clear/not clear - clinical assessment visually and by palpation
timeFrame: 3 months after treatment
measure: Erythema (redness) (none/mild/moderate/severe)
timeFrame: Immediately after PDT
measure: fluorescence assessed as none/mild/moderate/strong using Wood's light examination
timeFrame: Immediately before and after PDT
measure: patient preference - preferred right or left side or no preference
timeFrame: 24h
measure: swelling
timeFrame: immediately after PDT
measure: Exudation
timeFrame: immediately after PDT
measure: urticaria
timeFrame: immediately after PDT
Other outcomes:
measure: Blinding - patient will be asked which side they think the menthol was used on or if they do not know
timeFrame: 24h
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and medical School
Study officials:
affiliation: University of Dundee
name: Sally H Ibbotson, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
References: