Status:
ENROLLING_BY_INVITATION
Efficacy of Topical 85% TCA in the Treatment of LSIL After Low-grade Abnormality of Screening Test: a Randomized Controlled Trial
Lead Sponsor:
Department of Medical Services Ministry of Public Health of Thailand
Conditions:
Cervical Intraepithelial Neoplasia
Trichloroacetic Acid
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
To determine the efficacy and HPV clearance of an application of 85% TCA compared to placebo in the treatment of LSIL. This is a randomized, single-blind, placebo-controlled study in 44 women aged 18-...
Detailed Description
The study aims to determine the efficacy and HPV clearance of an application of 85% TCA compared to placebo in the treatment of LSIL. This study will be conducted in women aged 18-65 years with colpos...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Women, 18-65 years of age, colposcopic biopsy confirmed CIN1 or HPV (LSIL) preceded by low-grade cervical screening test, i.e. ASCUS HPV positive, LSIL, HPV 16/18 positive, persistent high-risk HPV infection.
- Willing to participate in this trial
- Exclusion criteria
- Women diagnosed with previous or concurrent invasive carcinoma of the cervix
- Women with history of pelvic radiotherapy
- Pregnant women
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06525870
Start Date
August 1 2024
End Date
September 30 2025
Last Update
November 14 2024
Active Locations (1)
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1
Rajavithi Hospital
Thailand, Bangkok, Thailand, 10400