A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses

NCT02520700 | Completed

• 1 other identifier: 00001
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Photodynamic therapy (PDT) uses visible light to treat a premalignant condition, called actinic keratosis, which results on chronically sun exposed skin such as on a balding scalp. A cream is applied containing aminolaevulinic acid or methyl aminolaevulinate and this is converted in the cells to the photodegradable product protoporphyrin IX (PpIX). Visible light causes the degradation of PpIX resulting in the production of reactive oxygen species and then cell death in the actinic keratosis. In conventional PDT a lamp is used to supply the visible light. The main draw back to treatment is pain. Recent studies have shown that daylight can be used as the source of visible light and is as effective as conventional PDT. Patients find this form of treatment less painful and therefore preferable. The reduction in pain seen in daylight PDT appears to be related to the fact that no significant quantity of PpIX accumulates prior to exposure to the light source and small quantities of PpIX are activated continuously during daylight exposure. The drawback of performing daylight PDT in Ireland is the climate, both in terms of cloud cover and temperature. The typical daylight treatment times is 2 hours and it would be difficult for patients to stay outside in winter, spring and autumn. This study investigates the use of an artificial white light source, a Maquet PWD 50SF theatre-light, as an alternative.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• The reduction in the actinic keratosis count per treatment field

  Palpable AKs within those areas defined as treatment fields will be counted, mapped and photographed at baseline and at 1, 3, 6 and 9 months

  9 months follow up

Secondary Outcomes (3)

• Pain scores on visual analogue scale (VAS) at 1, 30, 60, 90 and 120 minutes during treatment

  2 hours of treatment duration

• Patient satisfaction with treatment, on a scale of zero to ten

  At follow up one to three days post treatment

• Erythema or erosions (mild/moderate/severe)

  1 - 3 days post treatment

Study Arms (1)

Study participants

EXPERIMENTAL

This was split scalp design - so each patient had one half of scalp treated with daylight PDT and one side treated with the artificial white light PDT - a surgical light (Maquet Power 500 LED surgery light)

Device: Daylight and Maquet Power 500 LED surgery light

Interventions

Daylight and Maquet Power 500 LED surgery light DEVICE

Comparing the use of daylight and a surgical light (Maquet Power 500 LED surgery light) to activate ALA cream for treatment of actinic keratoses

Study participants

Eligibility Criteria

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

You may qualify if:

• patient requiring treatment for actinic keratoses on forehead or scalp

You may not qualify if:

• immunosuppressed patients, those with abnormal photosensitivity, contact allergy to topical therapy for use in the study or pregnancy and breastfeeding

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

Related Publications (1)

• O'Gorman SM, Clowry J, Manley M, McCavana J, Gray L, Kavanagh A, Lally A, Collins P. Artificial White Light vs Daylight Photodynamic Therapy for Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2016 Jun 1;152(6):638-44. doi: 10.1001/jamadermatol.2015.5436.

  PMID: 26843523 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Dermatologist

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 13, 2015
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08