Efficacy of Topical 85% TCA in the Treatment of LSIL After Low-grade Abnormality of Screening Test: a Randomized Controlled Trial

NCT06525870 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: 136/2567
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and HPV clearance of an application of 85% TCA compared to placebo in the treatment of LSIL. This is a randomized, single-blind, placebo-controlled study in 44 women aged 18-65 years with histologic-proved HPV/CIN1. The study will test whether 85% TCA application will be effective treatment in LSIL. The clinical study hypothesis is that TCA application at cervical lesion and transformation zone will achieve histologic complete remission of LSIL in significantly more patients than placebo therapy. Patients will be randomized to placebo (3% acetic acid) or 85%TCA topical application at cervical lesion and transformation zone. After 3 months, cytology, colposcopy, histology, and HPV testing will be performed. The primary endpoint is treatment efficacy defined as complete histologic remission at 3 months after treatment. The secondary endpoint is HPV clearance 3 months after treatment. The protocol for the project is approved by an Institutional Review Board (IRB). Project is totally supported by a grant from Rajavithi Hospital. There is no external funding.

Conditions

Cervical Intraepithelial Neoplasia; Trichloroacetic Acid

Keywords

CIN1; HPV; Trichloroacetic Acid; Low-grade squamous intraepithelial lesion; LSIL; Low-grade lesion

Outcome Measures

Primary Outcomes (1)

• Complete histologic remission at 3 months

  Complete remission (histologic cure) is defined as biopsy-proved normal histology at the time of final colposcopy/biopsy examination at 3-month follow-up.

  3 months

Secondary Outcomes (1)

• Type-specific HPV clearance at 3 months after treatment

  3 months

Study Arms (2)

Group 1

EXPERIMENTAL

Participants will receive 85%TCA topical application at cervical lesion and transformation zone. Application of TCA will be guided by colposcopy using a small cotton-tipped applicators and wooden end of the applicators.

Drug: 85%TCA topical application

Group 2

PLACEBO COMPARATOR

Participants will receive 3% acetic acid topical application at cervical lesion and transformation zone. Application of 3% acetic acid will be guided by colposcopy using a small cotton-tipped applicators and wooden end of the applicators.

Drug: 3% acetic acid

Interventions

85%TCA topical application DRUG

85%TCA topical application is done at cervical lesion and transformation zone. Application of TCA will be guided by colposcopy using a small cotton-tipped applicators and wooden end of the applicators. A thin film of TCA will be applied to cover the lesion and transformation zone.

Also known as: Group 1

Group 1

3% acetic acid DRUG

3% acetic acid topical application is done at cervical lesion and transformation zone. Application will be guided by colposcopy using a small cotton-tipped applicators and wooden end of the applicators. A thin film of acetic acid will be applied to cover the lesion and transformation zone.

Also known as: Group 2

Group 2

Eligibility Criteria

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

You may qualify if:

• Women, 18-65 years of age, colposcopic biopsy confirmed CIN1 or HPV (LSIL) preceded by low-grade cervical screening test, i.e. ASCUS HPV positive, LSIL, HPV 16/18 positive, persistent high-risk HPV infection.
• Willing to participate in this trial

You may not qualify if:

• Women diagnosed with previous or concurrent invasive carcinoma of the cervix
• Women with history of pelvic radiotherapy
• Pregnant women

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Thailand, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The treatment is unknown to the patient but the physicians will know because the different degree of cervical tissue whitening.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients then will be randomized between the two groups. Group 1 will be intervention arm and receive 85%TCA topical application at cervical lesion and transformation zone. Group 2 will be control arm and receive topical application of 3% acetic acid at cervical lesion and transformation zone in the same manner.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-07

Locations

TH (1)