a study of menthol for pain relief during photodynamic therapy

A randomised double blind, placebo controlled study of the efficacy of topical menthol for pain relief during topical photodynamic therapy. - A study of menthol for pain relief during photodynamic therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002849-59-GB

Enrollment

Registered

2018-08-02

Start date

2018-02-07

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Sk

Interventions

Product Name: Menthol 5% in aqueous cream Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of administration of the placebo: C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): 1. Phototoxicity 2. Patient evaluation 3. Efficacy 4. Fluorescence ; Timepoint(s) of evaluation of this end point: 1. immediately after PDT 2. 24h after PDT 3. 3 months after PDT 4. Immediately before PDT	—

Countries

United Kingdom

Contacts

Public ContactCatrina Forde

University of Dundee

c.forde@dundee.ac.uk01382383890

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026