Clinical trial · Interventional
Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis
Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis
NCT03805737CI-TRIAL-00056035completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to understand better if indoor daylight Photo Dynamic Therapy (PDT) can provide effective lesion clearing versus conventional red lamp light therapy.
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 Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amulez and red light treatment | Other | — | UNRESOLVED |
| Amulez and sunlight | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Indoor Daylight PDT Therapy
- description
- Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will be exposed to natural sunlight through a window for 2 hours. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.
- interventionNames
- Other: Amulez and sunlight
- type
- ACTIVE_COMPARATOR
- label
- FDA Approved Standard Light Therapy Treatment
- description
- Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will receive Red Light Treatment for 10 minutes. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.
- interventionNames
- Other: Amulez and red light treatment
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment. * Age ≥ 18 years older. Exclusion Criteria: * Pregnant women or women who are breast-feeding. * Any patients with a condition that makes them not suitable for clinical PDT.
References
Publications (10)
- BACKGROUNDZhao B, He YY. Recent advances in the prevention and treatment of skin cancer using photodynamic therapy. Expert Rev Anticancer Ther. 2010 Nov;10(11):1797-809. doi: 10.1586/era.10.154. PMID 21080805
- BACKGROUNDWiegell SR, Wulf HC, Szeimies RM, Basset-Seguin N, Bissonnette R, Gerritsen MJ, Gilaberte Y, Calzavara-Pinton P, Morton CA, Sidoroff A, Braathen LR. Daylight photodynamic therapy for actinic keratosis: an international consensus: International Society for Photodynamic Therapy in Dermatology. J Eur Acad Dermatol Venereol. 2012 Jun;26(6):673-9. doi: 10.1111/j.1468-3083.2011.04386.x. Epub 2011 Dec 23. PMID 22211665
- BACKGROUNDGriffin LL, Lear JT. Photodynamic Therapy and Non-Melanoma Skin Cancer. Cancers (Basel). 2016 Oct 22;8(10):98. doi: 10.3390/cancers8100098. PMID 27782094
- BACKGROUNDZhao SG, Chen XF, Wang LG, Yang G, Han DY, Teng L, Yang MC, Wang DY, Shi C, Liu YH, Zheng BJ, Shi CB, Gao X, Rainov NG. Increased expression of ABCB6 enhances protoporphyrin IX accumulation and photodynamic effect in human glioma. Ann Surg Oncol. 2013 Dec;20(13):4379-88. doi: 10.1245/s10434-011-2201-6. Epub 2012 Jun 12. PMID 22688660
- BACKGROUNDTyrrell JS, Morton C, Campbell SM, Curnow A. Comparison of protoporphyrin IX accumulation and destruction during methylaminolevulinate photodynamic therapy of skin tumours located at acral and nonacral sites. Br J Dermatol. 2011 Jun;164(6):1362-8. doi: 10.1111/j.1365-2133.2011.10265.x. Epub 2011 May 13. PMID 21564050
- BACKGROUNDNissen CV, Philipsen PA, Wulf HC. Protoporphyrin IX formation after topical application of methyl aminolaevulinate and BF-200 aminolaevulinic acid declines with age. Br J Dermatol. 2015 Sep;173(3):760-6. doi: 10.1111/bjd.13923. Epub 2015 Aug 20. PMID 25997508
- BACKGROUNDKanick SC, Davis SC, Zhao Y, Hasan T, Maytin EV, Pogue BW, Chapman MS. Dual-channel red/blue fluorescence dosimetry with broadband reflectance spectroscopic correction measures protoporphyrin IX production during photodynamic therapy of actinic keratosis. J Biomed Opt. 2014;19(7):75002. doi: 10.1117/1.JBO.19.7.075002.