a study of menthol for pain relief during photodynamic therapy

Phase 1

• Conditions: Actinic keratosis (pre-cancerous sun damage)on the face and scalp; MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002849-59-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-02
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Adults >18 years of age.
2. Able to give written informed consent.
3. Presence of actinic keratoses (AK) on the face and scalp involving both right and
left comparable sites.
4. Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the
potential treatment area that may cause difficulty with examination or final
evaluation.
5. Able to understand and adhere to protocol requirements.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Unable to give written informed consent.
2. Intolerance or allergy to menthol or placebo constituents
3.Participation in another drug trial or interventional study within 30 days of recruitment to this study
4. Premenopausal, pregnant, breastfeeding women or those planning to conceive
5.Chronic pain

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Is the pain of topical photodynamic therapy (PDT) significantly different when using menthol in aqueous cream applied before PDT compared with PDT using only placebo(aqueous cream). ;Secondary Objective: The fluorescence and inflammation (phototoxicity) caused by treatment and the outcome (efficacy) of treatment, along with the patient opinion of treatment.;Primary end point(s): Pain will be assessed by the patient using a visual analogue scale of 0-10. Pain will be assessed immediately after PDT (as per standard practice) and at the additional time-points of three, six and 24 hours after PDT. The patient-scored pain assessment at the first time point will be undertaken with the aid of a blinded investigator and subsequently the patient alone will assess symptoms.;Timepoint(s) of evaluation of this end point: Immediately after PDT and at 3h, 6h, 24 h after PDT.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Phototoxicity<br> 2. Patient evaluation<br> 3. Efficacy<br> 4. Fluorescence<br> ;<br> Timepoint(s) of evaluation of this end point: 1. immediately after PDT<br> 2. 24h after PDT<br> 3. 3 months after PDT<br> 4. Immediately before PDT<br>