Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545396
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterization Of The Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For The Treatment Of Actinic Keratoses And Their Cancerization Field
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy PDT with red light versus PDT with red light at half dose of illumination as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the scalp The main questions it aims to answer are
Does PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy
Does PDT with half-dose illumination protocol improve intervention tolerance
Researchers will compare both treatment protocols using the patient as its own control
Participants scalp will be divided in two halves one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol a skin biopsy will be obtained both pre and post-treatment of each of the areas Variables will be assessed during the 3 visits of the study
Does PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy
Does PDT with half-dose illumination protocol improve intervention tolerance
Researchers will compare both treatment protocols using the patient as its own control
Participants scalp will be divided in two halves one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol a skin biopsy will be obtained both pre and post-treatment of each of the areas Variables will be assessed during the 3 visits of the study
Detailed Description:
The goal of the clinical trial is to compare efficacy and tolerance of photodynamic therapy PDT with red light at half dose illumination protocol with conventional PDT for the treatment of grade I and II actinic keratosis The main hypotheses is that half-light protocol PDT could maintain efficacy while improving tolerance of the procedure
With this aim the investigators will compare the efficacy of the clinical response after field treatment with photodynamic therapy with red light at half dose versus conventional photodynamic therapy with standard red light in patients with scalp actinic keratoses as well as determine changes in molecular biomarkers at the histological and immunohistochemical level pre- and post-treatment with conventional PDT and PDT with red light at half dose
The included patients will have their scalp divided into two halves of similar size using the interparietal line as a separation method one half will be treated with conventional PDT and the other half with half-dose PDT This is a comparative study between two treatment modalities both of which will be applied to all patients and in half of the sample four skin biopsies of the affected area two pre and tw post-treatment will also be performed to conduct an immunohistochemical analysis of the skin samples Both treatment protocols will be compared using the patient as his or her own protocol Variables will be assessed during the 3 visits of the study baseline 3 months and 6 months
With this aim the investigators will compare the efficacy of the clinical response after field treatment with photodynamic therapy with red light at half dose versus conventional photodynamic therapy with standard red light in patients with scalp actinic keratoses as well as determine changes in molecular biomarkers at the histological and immunohistochemical level pre- and post-treatment with conventional PDT and PDT with red light at half dose
The included patients will have their scalp divided into two halves of similar size using the interparietal line as a separation method one half will be treated with conventional PDT and the other half with half-dose PDT This is a comparative study between two treatment modalities both of which will be applied to all patients and in half of the sample four skin biopsies of the affected area two pre and tw post-treatment will also be performed to conduct an immunohistochemical analysis of the skin samples Both treatment protocols will be compared using the patient as his or her own protocol Variables will be assessed during the 3 visits of the study baseline 3 months and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None