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

NCT06188104 | Withdrawn Phase 2 DMC

• 1 other identifier: 154/2566
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

CIN1; Trichloroacetic Acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain after treatment which evaluated by using visual analogue scale

  immediately after intervention, up to 2 weeks after intervention

• Having leukorrhea or not? which is recorded by questionnaire

  immediately after intervention, up to 2 weeks after intervention

• Having abnormal vaginal bleeding or not? which is recorded by questionnaire

  immediately after intervention, up to 2 weeks after intervention

Study Arms (6)

TCA plus acetic acid 1

EXPERIMENTAL

No lesion group,

Drug: Trichloroacetic acid

Acetic acid 1

NO INTERVENTION

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

TCA plus acetic acid 2

EXPERIMENTAL

Having lesion with normal pathologic examination

Drug: Trichloroacetic acid

Acetic acid 2

NO INTERVENTION

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

Having lesion with low-grade abnomality on pathologic examination,

Drug: Trichloroacetic acid

Acetic acid 3

NO INTERVENTION

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

Interventions

Trichloroacetic acid 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)

Also known as: Trichloroacetic acid plus Acetic acid

TCA plus acetic acid 1; TCA plus acetic acid 2; TCA plus acetic acid 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Phaya Thai, Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Trichloroacetic Acid; Acetic Acid

Intervention Hierarchy (Ancestors)

Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: January 3, 2024
• Study Start: November 30, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-08

Locations

TH (1)