Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577311
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ SCCis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid Hydrochloride Topical Gel 10 Ameluz With RhodoLED-XL Red Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ SCCis
Status:
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 test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face using a light-sensitive gel used in combination with a light source
The main questions this trial aims to answer are
to confirm using laboratory testing how much of the affected facial skin cancer section the treatment was able to remove and
seeing how many participants had no remaining affected facial skin cancer sections after treatment
Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments after voluntarily consent has been given
The main questions this trial aims to answer are
to confirm using laboratory testing how much of the affected facial skin cancer section the treatment was able to remove and
seeing how many participants had no remaining affected facial skin cancer sections after treatment
Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments after voluntarily consent has been given
Detailed Description:
In the study participants will be asked to complete the following
Provide basic personal information including date of birth gender race and ethnicity
Provide their medical surgical history and perform a medical exam including but not limited to symptom-directed physical exam skin type vital signs height weight and urine pregnancy test collection
Follow study rules such as avoiding certain medications and treatments
Provide information on any medications treatments or reactions that started after the study began
Allow two treatments on the skin cancer area of the face using a light-sensitive cream used in combination with a light source
Allow clinical documentation of the treatment such as how well the treatment was tolerated any skin reaction or side effects
Allow surgery to remove the skin cancer area from the face for Laboratory testing
To qualify for this trial participants must
be an adult 18 years of age or older
give voluntary written consent
have a recently diagnosed less than six months from first visit skin cancer area on the face that meets surgery size requirements
be willing to follow study instructions and complete study requirements including not using non-approved lotions and creams on the treatments areas
allow photographs of the area of skin cancer being treated on the face
if female not be pregnant before and during the study and agree to use acceptable forms of birth control
confirm they are not sensitive to any of the study treatment ingredients
All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing All photographs of the treatment area collected during the study will be used as study data
All participants have the right to refuse further participation in the study at any time
Provide basic personal information including date of birth gender race and ethnicity
Provide their medical surgical history and perform a medical exam including but not limited to symptom-directed physical exam skin type vital signs height weight and urine pregnancy test collection
Follow study rules such as avoiding certain medications and treatments
Provide information on any medications treatments or reactions that started after the study began
Allow two treatments on the skin cancer area of the face using a light-sensitive cream used in combination with a light source
Allow clinical documentation of the treatment such as how well the treatment was tolerated any skin reaction or side effects
Allow surgery to remove the skin cancer area from the face for Laboratory testing
To qualify for this trial participants must
be an adult 18 years of age or older
give voluntary written consent
have a recently diagnosed less than six months from first visit skin cancer area on the face that meets surgery size requirements
be willing to follow study instructions and complete study requirements including not using non-approved lotions and creams on the treatments areas
allow photographs of the area of skin cancer being treated on the face
if female not be pregnant before and during the study and agree to use acceptable forms of birth control
confirm they are not sensitive to any of the study treatment ingredients
All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing All photographs of the treatment area collected during the study will be used as study data
All participants have the right to refuse further participation in the study at any time
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