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

Rajavithi Hospital

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: CIN1; Trichloroacetic Acid

Treatments: Drug: Trichloroacetic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06188104

154/2566

Details and patient eligibility

About

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

Full 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

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 6 patient groups

TCA plus acetic acid 1

Experimental group

Description:

No lesion group,

Treatment:

Drug: Trichloroacetic acid

Acetic acid 1

No Intervention group

Description:

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

TCA plus acetic acid 2

Experimental group

Description:

Having lesion with normal pathologic examination

Treatment:

Drug: Trichloroacetic acid

Acetic acid 2

No Intervention group

Description:

Having lesion with normal pathologic examination, Applying acetic acid which normally used during colposcopic examination at transformation zone and lesion during colposcopic examination

TCA plus acetic acid 3

Experimental group

Description:

Having lesion with low-grade abnomality on pathologic examination,

Treatment:

Drug: Trichloroacetic acid

Acetic acid 3

No Intervention group

Description:

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