Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623201
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions
Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion These types of treatment can cause scarring Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart The light used can cause the skin to feel warm but does not cause scarring
Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion These types of treatment can cause scarring Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart The light used can cause the skin to feel warm but does not cause scarring
Detailed Description:
Blue light PDT has shown some success in treating BCCs but more research is needed to evaluate this treatment modality further The objective of this study is to evaluate the safety and efficacy of using photodynamic Therapy with Sonidegib for the treatment of multiple nodular basal cell carcinomas Participants who meet eligibility criteria at baseline will receive Sonidegib 200 mg by mouth every day for 3 months Participants will undergo three PDT sessions with topical application of ALA at Day 7 Day 30 and Day 90
The drug applied to the skin before the light treatment is an FDA approved drug called Levulan and has no known side effects The light used to treat the lesion is blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator Levulan-PDT This treatment regimen is approved by the FDA to treat actinic keratoses but is not approved to treat basal cell carcinoma Use of the light can feel warm and may sting
Sonidegib Odomzo is a compound that was approved by the US Food and Drug Administration in July 2015 as a treatment option for BCC Patients on Sonidegib may experience leg cramps taste disturbance or alopecia
The drug applied to the skin before the light treatment is an FDA approved drug called Levulan and has no known side effects The light used to treat the lesion is blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator Levulan-PDT This treatment regimen is approved by the FDA to treat actinic keratoses but is not approved to treat basal cell carcinoma Use of the light can feel warm and may sting
Sonidegib Odomzo is a compound that was approved by the US Food and Drug Administration in July 2015 as a treatment option for BCC Patients on Sonidegib may experience leg cramps taste disturbance or alopecia
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