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Clinical trial

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

ID
Name
154/2566
Description
To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test
Trial arms
Trial start
2023-11-30
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Withdrawn
Phase
Early phase I
Treatment
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)
Arms:
TCA plus acetic acid 1, TCA plus acetic acid 2, TCA plus acetic acid 3
Other names:
Trichloroacetic acid plus Acetic acid
Primary endpoint
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)
6 months after intervention
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-01-03

1 organization

1 product

2 indications

Organization
Rajavithi Hospital
Product
Trichloroacetic acid
Indication
Cervical Intraepithelial Neoplasia 1 (CIN1)
Indication
Trichloroacetic acid