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Menthol for PDT Pain Relief (MentholPDT)

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ClinicalTrials.gov Identifier: NCT02984072
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Dundee

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
Actinic Keratosis Drug: Menthol Drug: Aqueous Cream 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : October 23, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Active Comparator: Menthol
5% menthol in aqueous cream (Dermacool Forte)
Drug: Menthol
Topical menthol in aqueous cream
Other Name: 5% menthol in aqueous cream

Placebo Comparator: Placebo
Aqueous cream
Drug: Aqueous Cream
placebo
Other Name: placebo




Primary Outcome Measures :
  1. Pain immediately after PDT assessed by VAS score [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24h ]
    patient questionnaire completed at home and returned in SAE

  5. swelling [ Time Frame: immediately after PDT ]
    Swelling present or absent will be recorded on each side in each patient

  6. Exudation [ Time Frame: immediately after PDT ]
    Exudation present or absent will be recorded on each side in each patient

  7. urticaria [ Time Frame: 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 [ Time Frame: 24h ]
    patient questionnaire completed at home and returned in SAE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984072


Contacts
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Contact: Sally H Ibbotson, MBChB, MD 01382383499 s.h.ibbotson@dundee.ac.uk
Contact: Patricia Burns 01382 383297 p.burns@dundee.ac.uk

Locations
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United Kingdom
Ninewells Hospital and medical School Recruiting
Dundee, United Kingdom, DD1 9SY
Principal Investigator: Sally Ibbotson         
Sponsors and Collaborators
University of Dundee
Investigators
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Principal Investigator: Sally H Ibbotson, MBChB, MD University of Dundee

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Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT02984072     History of Changes
Other Study ID Numbers: 2015PQ01
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Findings of study will be shared through peer reviewed publications and presentations, although individual participant data not disclosed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Menthol
Antipruritics
Dermatologic Agents