Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis

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.

Study Overview

• Status: Withdrawn
• Conditions: Actinic Cheilitis
• Intervention / Treatment: Drug: TCA

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCA peal; Patients will have their actinic cheilitis treated with a TCA peal.	Drug: TCA; Patients will receive a TCA peel as a treatment for their actinic cheilitis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	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.	6 months
Healing Time	Determine the average healing time following TCA lip treatments- self reported	6 months

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Cheilitis
• Other Study ID Numbers: 1026120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be used outside the confines of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes