Menthol for PDT Pain Relief

NCT02984072 | Completed Phase 4

• 1 other identifier: 2015PQ01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Pain immediately after PDT assessed by VAS score

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

  24h

Secondary Outcomes (7)

• Clearance: clear/partially clear/not clear - clinical assessment visually and by palpation

  3 months after treatment

• Erythema (redness) (none/mild/moderate/severe)

  Immediately after PDT

• fluorescence assessed as none/mild/moderate/strong using Wood's light examination

  Immediately before and after PDT

• patient preference - preferred right or left side or no preference

  24h

• swelling

  immediately after PDT

Other Outcomes (1)

• Blinding - patient will be asked which side they think the menthol was used on or if they do not know

  24h

Study Arms (2)

Menthol

ACTIVE COMPARATOR

5% menthol in aqueous cream (Dermacool Forte)

Drug: Menthol

Placebo

PLACEBO COMPARATOR

Aqueous cream

Drug: Aqueous Cream

Interventions

Menthol DRUG

Topical menthol in aqueous cream

Also known as: 5% menthol in aqueous cream

Menthol

Aqueous Cream DRUG

placebo

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18 years. Target population is men or women ≥50 years (only post-menopausal women)
• Presence of actinic keratoses (AK) on the face and scalp involving both right and left comparable sites.
• Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
• Able to understand and adhere to protocol requirements.

You may not qualify if:

• Unable to give written informed consent.
• Allergy to menthol, aqueous cream or excipients
• Participation in a drug trial or other interventional study within 30 days of recruitment to this study
• Pre-menopausal women, pregnancy, breast feeding, planning to conceive
• Chronic pain

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Ninewells Hospital and medical School

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Menthol

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Study Officials

• Sally H Ibbotson, MBChB, MD

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: December 6, 2016
• Study Start: October 23, 2018
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)