Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461442
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-17
First Post:
2024-06-10
Brief Title:
Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis A Prospective Randomized Controlled Intra-Individual Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 effectiveness and safety of two treatments-cryotherapy and 5-Fluorouracil 5-FU-for actinic keratosis a common skin condition caused by long-term sun exposure Cryotherapy is a treatment that uses extreme cold produced by liquid nitrogen to freeze and destroy abnormal cells and 5-FU is a topical cream applied to the skin to treat lesions by interfering with cell growth The main questions this trial aims to answer are
Which treatment cryotherapy or 5-FU is more effective in reducing the number of actinic keratosis lesions
What are the side effects associated with each treatment
How do these treatments impact patient satisfaction cosmetic outcomes and health-related quality of life
Participants will
Undergo a baseline assessment where their demographics information such as age sex race smoking status and medical history are recorded along with the number and severity of actinic keratosis lesions
Receive both cryotherapy and 5-FU with each treatment applied to different areas of their body The area of the body to receive each treatment is decided by a random process like flipping a coin
Complete weekly surveys to monitor for side effects during and after the treatment period
Return to the clinic for follow-up assessments at 3 months and 12 months
Which treatment cryotherapy or 5-FU is more effective in reducing the number of actinic keratosis lesions
What are the side effects associated with each treatment
How do these treatments impact patient satisfaction cosmetic outcomes and health-related quality of life
Participants will
Undergo a baseline assessment where their demographics information such as age sex race smoking status and medical history are recorded along with the number and severity of actinic keratosis lesions
Receive both cryotherapy and 5-FU with each treatment applied to different areas of their body The area of the body to receive each treatment is decided by a random process like flipping a coin
Complete weekly surveys to monitor for side effects during and after the treatment period
Return to the clinic for follow-up assessments at 3 months and 12 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None