Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis

Phase 4

Withdrawn

• Conditions: Actinic Cheilitis
• Interventions: Drug: TCA

• Registration Number: NCT04744103
• Lead Sponsor: Nova Scotia Health Authority

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.

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.

Study Timeline

• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-08
• Study Start: 2023-09-15
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Inclusion criteria will include all patients with actinic cheilitis that do not meet exclusion criteria.

Exclusion Criteria

• Exclusion criteria will include patients younger than 18 years of age and patients with a biopsy proven malignancy of the lip.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TCA peal	TCA	Patients will have their actinic cheilitis treated with a TCA peal.

Primary Outcome Measures

Name	Time	Method
Treatment Number	3 months	Establish the average number of treatments required to achieve remission.
Recurrence Rate	6 months	Determine the recurrence rate of actinic cheilitis following topical TCA treatment
Remission rate	3 months	Determine the remission rate of actinic cheilitis following topical TCA treatment.
Adverse Events	3 months	Identify the common adverse events, if any, associated with topical TCA lip peels and determine their incidence.

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	6 months	Identify patient satisfaction before and after TCA treatment using the Skindex 16 survey developed by the University of California. This survey looks at how bothered patients are by a skin condition, with a higher score representing a more severe condition. The survey will be completed before and after treatment and the improvement in the score will be analyzed. There are 16 questions, each with a max score of 6, making the total survey score out of 96 and a minimum score of 0. A higher score indicates a poor quality of life attributed to the described skin condition.
Healing Time	6 months	Determine the average healing time following TCA lip treatments- self reported

Trial Locations

Locations (1)

QEII; 🇨🇦 Halifax, Nova Scotia, Canada