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MentholPDT: Menthol for PDT Pain Relief

Sponsor
University of Dundee (Other)
Overall Status
Completed
CT.gov ID
NCT02984072
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
11.6
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised Double Blind, Placebo Controlled Study of the Efficacy of Topical Menthol for Pain Relief During Topical Photodynamic Therapy
Actual Study Start Date :
Oct 23, 2018
Actual Primary Completion Date :
Oct 10, 2019
Actual Study Completion Date :
Oct 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Menthol

5% menthol in aqueous cream (Dermacool Forte)

Drug: Menthol
Topical menthol in aqueous cream
Other Names:
  • 5% menthol in aqueous cream

    		•
    Placebo Comparator: Placebo

    Aqueous cream

    Drug: Aqueous Cream
    placebo
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain immediately after PDT assessed by VAS score [24h]

      pain immediately after and at 3, 6 and 24 h after PDT assessed by VAS score

    Secondary Outcome Measures

    1. Clearance: clear/partially clear/not clear - clinical assessment visually and by palpation [3 months after treatment]

      Clearance (CR), partial clearance (PR) or no clearance (NR) will be recorded on each side in each participant

    2. Erythema (redness) (none/mild/moderate/severe) [Immediately after PDT]

      Erythema grading (none/mild/moderate/severe) will be recorded on each side in each participant

    3. fluorescence assessed as none/mild/moderate/strong using Wood's light examination [Immediately before and after PDT]

      Fluorescence of each side in each participant will be recorded

    4. patient preference - preferred right or left side or no preference [24h]

      patient questionnaire completed at home and returned in SAE

    5. swelling [immediately after PDT]

      Swelling present or absent will be recorded on each side in each patient

    6. Exudation [immediately after PDT]

      Exudation present or absent will be recorded on each side in each patient

    7. urticaria [immediately after PDT]

      Urticaria present or absent will be recorded on each side in each patient

    Other Outcome Measures

    1. Blinding - patient will be asked which side they think the menthol was used on or if they do not know [24h]

      patient questionnaire completed at home and returned in SAE

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ninewells Hospital and medical School Dundee United Kingdom DD1 9SY

    Sponsors and Collaborators

    • University of Dundee

    Investigators

    • Principal Investigator: Sally H Ibbotson, MBChB, MD, University of Dundee

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Dundee
    ClinicalTrials.gov Identifier:
    NCT02984072
    Other Study ID Numbers:
    • 2015PQ01
    First Posted:
    Dec 6, 2016
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Keratosis, Actinic
    Keratosis
    Menthol

    Study Results

    No Results Posted as of Mar 9, 2021