CIN1Phase 2/3NCT06188104
Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test
A Phase 2/3 study testing Trichloroacetic acid in people with CIN1 and Trichloroacetic Acid, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- CIN1, Trichloroacetic Acid
- What is being tested?
- Trichloroacetic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteThailand
- Study dates
- 30 Nov 2023to 1 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test
Read the detailed 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
- Conditions
- CIN1, Trichloroacetic Acid
- Being tested
- Trichloroacetic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichloroacetic acidDrug
Also called Trichloroacetic acid plus Acetic 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)
| Study group | Role | What they receive |
|---|---|---|
| TCA plus acetic acid 1 | Experimental | No lesion group, Receives: 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 Receives: 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, Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after intervention
Secondary outcomes (3)
Pain after treatment which evaluated by using visual analogue scale
Sides effect of 95%Trichloroacetic acid
Measured: immediately after intervention, up to 2 weeks after intervention
Having leukorrhea or not? which is recorded by questionnaire
Sides effect of 95%Trichloroacetic acid
Measured: immediately after intervention, up to 2 weeks after intervention
Having abnormal vaginal bleeding or not? which is recorded by questionnaire
Sides effect of 95%Trichloroacetic acid
Measured: immediately after intervention, up to 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start30 Nov 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Why it stopped: I have found it is quite difficult to conduct the work without changing some detail in original protocol. So we would like to re-start the study again with some modification.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIN1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188104
- Sponsor's protocol ID
- 154/2566
- Status last verified
- Aug 2023
- First submitted
- 29 Sep 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06188104
- Acronym / sponsor ID
- 154/2566
- Conditions
- CIN1, Trichloroacetic Acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: I have found it is quite difficult to conduct the work without changing some detail in original protocol. So we would like to re-start the study again with some modification.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TCA plus acetic acid 1 | Experimental | Drug: Trichloroacetic acidNo lesion group, |
| 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 | Drug: Trichloroacetic acidHaving lesion with normal pathologic examination |
| 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 | Drug: Trichloroacetic acidHaving lesion with low-grade abnomality on pathologic examination, |
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trichloroacetic acidAlso: Trichloroacetic acid plus Acetic acidApplying 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) | Drug | TCA plus acetic acid 1, TCA plus acetic acid 2, TCA plus acetic acid 3 |
Primary outcome
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)
Time frame: 6 months after intervention
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
3 secondary outcomes
Pain after treatment which evaluated by using visual analogue scale
Time frame: immediately after intervention, up to 2 weeks after intervention
Having leukorrhea or not? which is recorded by questionnaire
Time frame: immediately after intervention, up to 2 weeks after intervention
Having abnormal vaginal bleeding or not? which is recorded by questionnaire
Time frame: immediately after intervention, up to 2 weeks after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Related trials for CIN1
Not yet recruitingPhase 1/2
Phase I/II Trial of Electroporation-Delivered pBI-4 Vaccine (TriGrid™ PVX4) for Treatment of Women With HPV16-Positive CIN1 or Persistent Infection
Cervical Intraepithelial Neoplasia Grade 1, Human Papillomavirus 16 Infection
Not yet recruitingPhase 2
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
HIV Infections, HPV Infection
Recruiting
Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.
Womens Health, Cervical Dysplasia
Active, not recruiting
Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)
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A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.
CIN - Cervical Intraepithelial Neoplasia, CIN 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trichloroacetic acid in people with CIN1 and Trichloroacetic Acid, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.