Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test

Efficacy of Topical 95% Trichloroaceteic Acid in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test: A Randomized Controlled Trial

To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test

Study Overview

• Status: Withdrawn
• Conditions: CIN1; Trichloroacetic Acid
• Intervention / Treatment: Drug: Trichloroacetic acid

Detailed Description

The patients meeting inclusion criteria were initially divided into two groups which are no lesion and having lesion at cervix on colposcopic examination.

Participant in no lesion group were divided into two group, recieving 95% Trichloroacetic acid (intervention) plus aceteic acid (commonly apply at cervix during colposcopic examination) applying to the cervix at T-zone and Acetic acid alone group.

We follow-up each group for 6 months to evaluate the outcome using cytologic examination, HPV testing and colposcopic examination (also biopsy if lesion is seen) compare to previous result (before treatment)

In the group having lesion at cervix, we initially biopsy the lesion and wait for pathologic result. If the pathologic results are high-grade lesion e.g. HSIL, we exclude them from this study. On the contrary, if the pathologic result s are low-grade lesion, we divided them into two group, normal pathologic exam and low-grade abnormality on pathologic examination. Both of them are divided into two groups and follow-up for 6 months, similar to the no lesion group

* During colposcopic examination, we also repeat cytologic examination and HPV testing as well

** Pregnancy test is done before applying 95%Trichloroacetic acid and at the time of follow-up. If positive at any point of time, participants are excluded from the study

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Phaya Thai, Bangkok, Thailand, 10400
      • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women who have low-grade abnormality result such as ASC-US, LSIL, HPV 16/18 positive, persistent HPV infection after cervical cancer screening test
• No history of endometrial or cervical cancer
• Pregnancy test negative
• Good communication in Thai language
• Vouluntarily participate to the study

Exclusion Criteria:

• Pregnancy test positive after participate in the study
• Pathologic result from colposcopic biopsy (before intervention) is high-grade abnormality such as HSIL, CIN2-3 or AIS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCA plus acetic acid 1; No lesion group,	Drug: Trichloroacetic acid; Applying Trichloroacetic acid 95 % topical solution plus acetic acid at the transformation zone or lesion (if have) of the cervix during colposcopic examination (95% topical trichloroacetic acid is used just before finishing examination, while acetic acid is used normally when perform colposcopy); Other Names: Trichloroacetic acid plus Acetic acid
No Intervention: Acetic acid 1; No lesion group, Applying acetic acid which normally used during colposcopic examination at transformation zone during colposcopic examination
Experimental: TCA plus acetic acid 2; Having lesion with normal pathologic examination	Drug: Trichloroacetic acid; Applying Trichloroacetic acid 95 % topical solution plus acetic acid at the transformation zone or lesion (if have) of the cervix during colposcopic examination (95% topical trichloroacetic acid is used just before finishing examination, while acetic acid is used normally when perform colposcopy); Other Names: Trichloroacetic acid plus Acetic acid
No Intervention: Acetic acid 2; Having lesion with normal pathologic examination, Applying acetic acid which normally used during colposcopic examination at transformation zone and lesion during colposcopic examination
Experimental: TCA plus acetic acid 3; Having lesion with low-grade abnomality on pathologic examination,	Drug: Trichloroacetic acid; Applying Trichloroacetic acid 95 % topical solution plus acetic acid at the transformation zone or lesion (if have) of the cervix during colposcopic examination (95% topical trichloroacetic acid is used just before finishing examination, while acetic acid is used normally when perform colposcopy); Other Names: Trichloroacetic acid plus Acetic acid
No Intervention: Acetic acid 3; Having lesion with low-grade abnomality on pathologic examination, Applying acetic acid which normally used during colposcopic examination at transformation zone and lesion during colposcopic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with cytologic examination, HPV testing and colposcopic examination with biopsy ( Efficacy of 95%Trichloroacetic acid in the treatment of CIN1 or less)	using cytologic examination, HPV testing and colposcopic examination with biopsy (if having lesion) compare to previous results If all of the test's results are normal, we consider it as remission of CIN1 or less *normal means: Cytologic examination = Negative for intraepithelial lesion or malignancy HPV testing = no HPV detected Colposcopic examination not seen any lesion = normal (not perform biopsy) Colposcopic examination with biopsy = normal pathlogic result	6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after treatment which evaluated by using visual analogue scale	Sides effect of 95%Trichloroacetic acid	immediately after intervention, up to 2 weeks after intervention
Having leukorrhea or not? which is recorded by questionnaire	Sides effect of 95%Trichloroacetic acid	immediately after intervention, up to 2 weeks after intervention
Having abnormal vaginal bleeding or not? which is recorded by questionnaire	Sides effect of 95%Trichloroacetic acid	immediately after intervention, up to 2 weeks after intervention

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Anti-Infective Agents; Anti-Bacterial Agents; Acetic Acid
• Other Study ID Numbers: 154/2566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No