Clinical trial · Observational
Biomarker Database Registry for Photodynamic Therapy
Biomarkers of Clinical Responsiveness to Photodynamic Therapy
- 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 research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Actinic Keratosis (AK) clearance
- timeFrame
- at 3 months post-treatment
- description
- Change in AK lesions present at 3 months post-PDT treatment
- measure
- Vitamin D levels
- timeFrame
- At baseline, which is the day of PDT treatment
- description
- Vitamin D level (25-hydroxy-cholecalciferol) measured in serum
Secondary outcomes (2)
- measure
- Allele polymorphisms in the gene of the Vitamin D receptor (VDR)
- timeFrame
- At baseline, which is the day of PDT treatment
- description
- Identify the allele combination present at VDR locus
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females, at least 18 years of age * Patient has nonhypertrophic actinic keratosis, at least 10 AK lesions present on the face, scalp, forearms, chest, or legs at the time of PDT treatment Exclusion Criteria: * taking doxycline, a photosensitizer * using topical retinoids, since these can exacerbate the post-PDT erythema reaction * pregnant
References
Publications (2)
- DERIVEDHeusinkveld LE, Bullock TA, Negrey J, Warren CB, Maytin EV. Sandpaper curettage: A simple method to improve PDT outcomes for actinic keratosis. Photodiagnosis Photodyn Ther. 2022 Dec;40:103050. doi: 10.1016/j.pdpdt.2022.103050. Epub 2022 Aug 3. PMID 35932960
- DERIVEDBullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18. PMID 35314199