Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744103
Status:
WITHDRAWN
Last Update Posted:
2021-08-16
First Post:
2021-01-31
Brief Title:
Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
This study has been on hold due to the COVID-19 pandemic Recruitment never began and the team didnt renew the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Actinic cheilitis is a condition of the lower lip characterized by grayish-white areas of discoloration and blunting of the demarcation between the cutaneous lip and the mucosa
While many studies have compared treatment options for actinic cheilitis there is still significant debate over how to best manage this condition The chosen treatment regimen must result in complete remission while also preventing recurrence and malignant transformation Current treatment options are vast including both non-surgical and surgical options Common topical therapies include 5-fluorouracil imiquimod ingenol mebutate and diclofenac More recently photodynamic therapy has been brought forward as a potential treatment modality From a surgical perspective a vermilionectomy is typically the procedure of choice
TCA is a popular topical treatment for treat fine rhytides hyperpigmentation photodamage and premalignant changes such as actinic keratoses Despite this TCA is not commonly used for actinic changes on the lips Here the investigators propose an expansion of the application of TCA to be used in the treatment of actinic cheilitis
While many studies have compared treatment options for actinic cheilitis there is still significant debate over how to best manage this condition The chosen treatment regimen must result in complete remission while also preventing recurrence and malignant transformation Current treatment options are vast including both non-surgical and surgical options Common topical therapies include 5-fluorouracil imiquimod ingenol mebutate and diclofenac More recently photodynamic therapy has been brought forward as a potential treatment modality From a surgical perspective a vermilionectomy is typically the procedure of choice
TCA is a popular topical treatment for treat fine rhytides hyperpigmentation photodamage and premalignant changes such as actinic keratoses Despite this TCA is not commonly used for actinic changes on the lips Here the investigators propose an expansion of the application of TCA to be used in the treatment of actinic cheilitis
Detailed Description:
The proposed study will be a prospective cohort study of all patients with actinic cheilitis presenting to the study institution the Queen Elizabeth II Health Science Center in Halifax from March 1st 2021- March 1st 2023
Patients will be consented to participate at the time of their initial consultation They will fill out the demographics form a preliminary survey and have the required photographs taken on that same day A biopsy will be performed prior to treatment to establish the histological grade of their actinic cheilitis based on the degree of dysplasia After the treatment is received they will follow-up in 1 month for reassessment At this point a second treatment will be offered if clinical remission has not been achieved Patients will continue TCA treatments at 1-month intervals until clinical remission is reached Once remission is achieved they will fill out the post-treatment questionnaire and have their second set of photos taken
Final follow-up will occur 6 months post remission At this point patients will be assessed for clinical recurrence A third set of photos will be completed during this appointment
Patients will be consented to participate at the time of their initial consultation They will fill out the demographics form a preliminary survey and have the required photographs taken on that same day A biopsy will be performed prior to treatment to establish the histological grade of their actinic cheilitis based on the degree of dysplasia After the treatment is received they will follow-up in 1 month for reassessment At this point a second treatment will be offered if clinical remission has not been achieved Patients will continue TCA treatments at 1-month intervals until clinical remission is reached Once remission is achieved they will fill out the post-treatment questionnaire and have their second set of photos taken
Final follow-up will occur 6 months post remission At this point patients will be assessed for clinical recurrence A third set of photos will be completed during this appointment
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?:
True
Is an FDA AA801 Violation?:
None