Clinical trial · Interventional
A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daylight and Maquet Power 500 LED surgery light | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study participants
- description
- 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)
- interventionNames
- Device: Daylight and Maquet Power 500 LED surgery light
Primary outcomes (1)
- measure
- The reduction in the actinic keratosis count per treatment field
- timeFrame
- 9 months follow up
- description
- 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
Secondary outcomes (3)
- measure
- Pain scores on visual analogue scale (VAS) at 1, 30, 60, 90 and 120 minutes during treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient requiring treatment for actinic keratoses on forehead or scalp Exclusion Criteria: * immunosuppressed patients, those with abnormal photosensitivity, contact allergy to topical therapy for use in the study or pregnancy and breastfeeding
References
Publications (1)
- DERIVEDO'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