TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)

Study Overview
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Brief Summary
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Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. The device system is to be used only in accordance with the approved Investigational Plan on subjects, who have given written informed consent. High remission and regression rates are expected after a single topical treatment with 85% TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1 normal squamous epithelium after the TCA treatment is equal to remission and will be counted as a remission in combined analysis. Remission is defined as complete histologic remission of CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance is defined as disappearance of the HPV type detected at screening.

Detailed Description
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Visit and assessment Schedule: Visit1 Screening: Informed Consent, Inclusion/Exclusion Criteria, Medical History, Gynecological Examination Cytology HPV Test Colposcopy Biopsy VAS (Visual analog scale) Pregnancy test Visit 2 Treatment Day with TCA 85%: Colposcopy TCA Treatment VAS Pregnancy test Visit 3, Control 1, Week 10-14: Cytology HPV Test Colposcopy Biopsy 4-quadrant biopsy ECC Adverse event monitoring If there is no sign of CIN during the colposcopic examination 10-14 weeks a 4-quadrant biopsy and a ECC are performed Visit 4, Control 2, Week 22-26: Cytology HPV Test Colposcopy Biopsy 4-quadrant biopsy ECC Adverse event monitoring Pregnancy test If there is no sign of CIN during the colposcopic examination 22-26 weeks after the TCA treatment, a 4-quadrant biopsy and a ECC are performed. Visit 5, EOS , Week 24-30: - Results Discussion

Official Title
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TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)

Conditions
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Cervical Intraepithelial Neoplasia Grade 1, Cervical Intraepithelial Neoplasia Grade 2

Intervention / Treatment
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* Device: Trichloroacetic acid 85% (TCA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven CIN 1/2 adequate colposcopy (i.e. fully visible transformation zone and margins of any visible lesion) positive HPV test conducted negative pregnancy test women aged 18 to 50 years written informed consent Exclusion Criteria: Exclusion criteria are a cytologically suspected CIN (Pap IIID, IV) inadequate colposcopy negative or missing biopsy cytology results indicating invasive disease (PAP V) if the cervical lesion recedes into the endocervical canal pregnancy any medical circumstance considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRICIN<br>If a patient is eligible local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application | Device: Trichloroacetic acid 85% (TCA)<br>* Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIN remission rate after treatment with TCA 85% | measured by histologic remission within 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIN regression rate after treatment with TCA 85% | measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months | 6 months | 
| Pain scores | measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2 | 6 months | 
| Type specific human papillomavirus clearance rate after treatment with TCA 85% | human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months | 6 months |