Actinic Keratosis Clinical Trial
Official title:
Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
This study is open to individuals with Actinic Keratoses (skin lesions that have the potential to turn into skin cancer), who are receiving photodynamic therapy (PDT) as part of their clinical care. The purpose of this study is to test and demonstrate that vitamin D pre-treatment can enhance PDT efficacy in the treatment of Actinic Keratoses. Participants will be asked to take vitamin D supplements prior to their standard of care PDT treatment. Participation in the research will last about 3-4 months.
The primary objective of this study is to determine whether acute supplementation (neoadjuvant Vitamin D3), adjusted according to baseline Vitamin D status, can improve the clinical PDT response relative to participants receiving PDT alone The secondary objective of this study is to determine whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness to Vitamin D as a neoadjuvant for PDT. This study is a non-randomized interventional trial, in which the study group will be compared to a baseline cohort of patients from a previous study who received the same regimen of PDT, but without any Vit D. It is anticipated that 30 participants will be involved in this study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03013647 -
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
|
N/A | |
| Completed |
NCT02674048 -
Metvix Daylight PDT in Actinic Keratosis
|
||
| Completed |
NCT02239679 -
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
|
Phase 2 | |
| Completed |
NCT02421471 -
PMS to Evaluate the Safety and Efficacy of Picato® Gel
|
||
| Completed |
NCT01686152 -
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
|
Phase 3 | |
| Completed |
NCT01444989 -
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
|
N/A | |
| Completed |
NCT01449513 -
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
|
Phase 1 | |
| Terminated |
NCT01525329 -
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
|
Phase 3 | |
| Terminated |
NCT01203878 -
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
|
Phase 4 | |
| Completed |
NCT00989313 -
A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study
|
Phase 3 | |
| Completed |
NCT00306800 -
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
|
Phase 3 | |
| Completed |
NCT00375739 -
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
|
Phase 2 | |
| Completed |
NCT03285490 -
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
|
Phase 3 | |
| Completed |
NCT03319251 -
Biomarker Database Registry for Photodynamic Therapy
|
||
| Completed |
NCT02866695 -
Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients
|
Phase 4 | |
| Completed |
NCT02952898 -
Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
|
Phase 3 | |
| Completed |
NCT02984072 -
Menthol for PDT Pain Relief
|
Phase 4 | |
| Recruiting |
NCT03684772 -
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
|
Phase 2 | |
| Completed |
NCT02878382 -
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
|
N/A | |
| Completed |
NCT02902822 -
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
|
N/A |