Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis

NCT04744103 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 1026120
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Cheilitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• patient satisfaction

  6 months

• Healing Time

  6 months

Study Arms (1)

TCA peal

EXPERIMENTAL

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

Drug: TCA

Interventions

TCA DRUG

Patients will receive a TCA peel as a treatment for their actinic cheilitis.

TCA peal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

QEII

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

• Kuta V, Taylor SM. Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis. OTO Open. 2025 May 23;9(2):e70132. doi: 10.1002/oto2.70132. eCollection 2025 Apr-Jun.

  PMID: 40416781 DERIVED

MeSH Terms

Conditions

Actinic cheilitis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 8, 2021
• Study Start: September 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)