Clinical trial · Interventional
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis
NCT03013647CI-TRIAL-00025370unknownN/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)
Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy. Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methyl Aminolevulinate | Drug | Methyl Aminolevulinate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Actinic Keratosis
- description
- Twenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area.
- interventionNames
- Drug: Methyl Aminolevulinate
Primary outcomes (1)
- measure
- Clinical improvement
- timeFrame
- 3 months after treatment
- description
- Counting of Actinic keratosis
Secondary outcomes (2)
- measure
- Histological changes
- timeFrame
- 3 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: -multiple (at least five) actinic keratosis on the face, grades I and II Exclusion Criteria: * phototypes IV, V and VI * patients treated for actinic keratosis up to 6 months before * history of allergy to methyl aminolevulinate * history of photoallergy * pregnancy
References
Publications (4)
- BACKGROUNDFargnoli MC, Piccioni A, Neri L, Tambone S, Pellegrini C, Peris K. Long-term efficacy and safety of daylight photodynamic therapy with methyl amninolevulinate for actinic keratosis of the face and scalp. Eur J Dermatol. 2017 Feb 1;27(1):89-91. doi: 10.1684/ejd.2016.2882. No abstract available. PMID 27748261
- BACKGROUNDGrinblat B, Galimberti G, Pantoja G, Sanclemente G, Lopez M, Alcala D, Torezan L, Kerob D, Pascual T, Chouela E. Feasibility of daylight-mediated photodynamic therapy for actinic keratosis throughout the year in Central and South America: a meteorological study. Int J Dermatol. 2016 Sep;55(9):e488-93. doi: 10.1111/ijd.13256. Epub 2016 Apr 7. PMID 27061814
- BACKGROUNDPhilipp-Dormston WG, Sanclemente G, Torezan L, Tretti Clementoni M, Le Pillouer-Prost A, Cartier H, Szeimies RM, Bjerring P. Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):8-15. doi: 10.1111/jdv.13327. Epub 2015 Nov 9. PMID 26552049
- BACKGROUNDGrinblat B, Galimberti G, Chouela E, Sanclemente G, Lopez M, Alcala D, Torezan L, Pantoja G. Daylight-mediated photodynamic therapy for actinic damage in Latin America: consensus recommendations. Photodermatol Photoimmunol Photomed. 2016 Mar;32(2):81-7. doi: 10.1111/phpp.12221. Epub 2015 Dec 9. PMID 26541910