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

CIN1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06188104
• Other study ID #: 154/2566
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: November 30, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• CIN1
• Congenital Abnormalities

Intervention

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)

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Phaya Thai	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Having leukorrhea or not? which is recorded by questionnaire	Sides effect of 95%Trichloroacetic acid	immediately after intervention, up to 2 weeks after intervention
Secondary	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