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

NCT ID: NCT06188104

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2023-12-01

Brief Summary

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

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

Conditions

CIN1; Trichloroacetic Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TCA plus acetic acid 1

No lesion group,

Group Type: EXPERIMENTAL

Trichloroacetic acid

Intervention Type: DRUG

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)

Acetic acid 1

No lesion group, Applying acetic acid which normally used during colposcopic examination at transformation zone during colposcopic examination

Group Type: NO_INTERVENTION

No interventions assigned to this group

TCA plus acetic acid 2

Having lesion with normal pathologic examination

Group Type: EXPERIMENTAL

Trichloroacetic acid

Intervention Type: DRUG

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)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

TCA plus acetic acid 3

Having lesion with low-grade abnomality on pathologic examination,

Group Type: EXPERIMENTAL

Trichloroacetic acid

Intervention Type: DRUG

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)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Trichloroacetic acid plus Acetic acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rajavithi hospital

Phaya Thai, Bangkok, Thailand

Countries

Thailand

Other Identifiers

154/2566

Identifier Type: -

Identifier Source: org_study_id