Squamous Intraepithelial Lesions of the CervixPAPILOCARENCT04624568

Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance

A study testing PAPILOCARE in people with Squamous Intraepithelial Lesions of the Cervix and Human Papilloma Virus Infection, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

clinical trial comparing the regression rate after 12 months of histologically confirmed cervical intraepithelial lesions 1 in 2 parallel groups. One group using the vaginal gel Papilocare® for 6 months and one group without any treatment. Read more about this study

Who is it for?: Ages 25 years and older, women only
Conditions the study is for: Squamous Intraepithelial Lesions of the Cervix, Human Papilloma Virus Infection, Cervix Lesion
What is being tested?: PAPILOCARE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteFrance
Study dates: 17 Nov 2020to 17 May 2023
Phase: Interventional
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 25 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women aged 25 years old or older.
With histologically-confirmed cervical intraepithelial lesion 1 only, proven by colposcopy biopsy, done in the most suspiscious area.
With complete colposcopy, performed less than 3 months prior the inclusion
With confirmed ASC-US or LSIL cervical-cytology, performed less than 6 months prior the colposcopy.

Who cannot join

Women under guardianship or curatorship
Women under the protection of justice
Women not affiliated with a social security system
Pregnant woman (as vaginal gel has not been evaluated in pregnant women) Urinary dosing of BHCG will be performed on the day of inclusion for all women under 55 years of age and effective contraception is recommended during the study for all non-menopausal women.
Immunodepressed women (HIV, immunosuppressive treatments ...)
Woman using vaginal contraceptives (ring, spermicides, cervical cap; because of risk of interaction) NB: Papilocare is compatible with the use of condoms and intrauterine devices.

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Known allergy to one of the components
Patients with low-grade histology with HSIL - ASC-H - AGC smear will not be included. The cyto-colposcopic discordance suggests a high-grade lesion that would not have been biopsied at colposcopy.
Patients undergoing laser or conization treatment according to the recommendations of INCa 2016 will not be included; namely: persistence of CIN 1 for more than 24 months on at least 2 different colposcopies; high-grade squamous intraepithelial histological lesions; adenocarcinoma in situ.
Participation in another interventional study

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Hospitalier Régional d'Orléans, France
Orléans, 45000

Other trials in France

About this study

Official title: Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance.

Read the detailed description

Cervical cancer affects 3000 women and causes 1100 deaths every year in France. This type of cancer usually takes about 10 to 15 years to develop and has distinct precursor stages. Persistent infection by Human Papillomavirus is necessary for the development of these lesions.

Currently, when a colposcopy biopsy reveals low grade lesion, it is recommanded to make a new cervical cytology or HPV testing, 12 months later. No treatment is recommended over this period. However 11% of these lesions evolve from low to high grade.

Papilocare® is a vaginal gel that would improve the re-epithelialization of the uterine cervix. Creating a protective film on the cervix, it could induce a favorable environment for regression of the cervical intraepithelial lesions 1 and for clearance of Human Papillomavirus.

The goal of our study is to include 150 women with a histologically confirmed cervical intraepithelial lesions 1. Half of them will be using the vaginal gel Papilocare® for 6 month while the other half will not receive any treatment (as suggested by current recommendations). Each patient will have a cervical cytology and a HPV testing after 6 months and after 12 months. Therefore we will be able to compare the percentage of normalization of cervical cytology and HPV clearance for each group after 6 months and after 12 months.

Patients will visit the Orleans hospital once for the inclusion and twice for follow-ups after 6 months and 12 months.

If the use of Papilocare® really induces a significant regression of low grade lesions, this vaginal gel could be offered as soon as these lesions are histologically identified in order to stop its progress to high grade.

Conditions: Squamous Intraepithelial Lesions of the Cervix, Human Papilloma Virus Infection, Cervix Lesion
Being tested: PAPILOCARE
Keywords: Cervical lesion, Cervical intraepithelial lesions 1, CIN1, Low grade lesion, Colposcopy, Cervical cytology, Human Papillomavirus, HPV infection, HPV testing, Vaginal gel, Papilocare®
Medical subject headings: Squamous Intraepithelial Lesions of the Cervix, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PAPILOCAREDevice
Papilocare® is a self-administered vaginal gel. Its single-dose cannula contains hyaluronic acid and pre-biotics (Coriolus Versicolor) that would improve the re-epithelialization of the uterin cervix. By creating a protective film on the cervix, this gel could induce a favorable environment for regression of the cervical intraepithelial lesions 1 and for clearance of Human Papillomavirus.
The specific approach related to our study would be to apply Papilocare® vaginal gel for 6 months for the treated group.
Smear and HPV test will be perform by all patients at 6 and 12 months.

Study groups in NCT04624568
Study group	Role	What they receive
Papilocare group	Experimental	Papilocare® for 6 months according to the following schedule: 1 self-applying single dose per day for 21 days over 28 during the first month, then 1 day over 2 during the following 5 months, with a 7-day break during the menstrual period. (This break must be respected even in menopausal women or women undergoing artificial amenorrhea (amenorrhea induced by certain contraceptives: implant, hormonal IUD, micro-progestogen). Receives: Device: PAPILOCARE
Control group	No intervention	No treatment for 12 months. Smear and HPV test will be perform by all patients at 6 and 12 months

What is being measured

The primary outcome is the main question the study is designed to answer.

Cervical cytology normalization after 12 months.
Compare the normalization rate of the cervical cytology in each arm after 12 months.
The difference will be considered statistically significant if the treatment group has a normalization rate of 25% or higher.
An "unsatisfactory" smear in its realization will have to be repeated within 45 days.
Measured: Month 12

Secondary outcomes (4)

Cervical cytology normalization after 6 months.
Compare the normalization rate of the cervical cytology in each arm after 6 months.
Measured: Month 6
HPV clearance after 6 months
1. Compare in each arm the rate of transition from a positive HPV testing at inclusion to a negative HPV testing after 6 months.
The difference will be considered statistically significant if the treatment group has a clearance rate of 25% or higher.
Measured: Month 6
HPV clearance after 12 months
1. Compare in each arm the rate of transition from a positive HPV testing at inclusion to a negative HPV testing after 12 months.
The difference will be considered statistically significant if the treatment group has a clearance rate of 25% or higher.
Measured: Month 12
Evaluation of tolerance of Papilocare vaginal gel
Compare in each group the number of episodes of vaginal discomfort over the first 6 months.
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 202017 May 2023

First posted12 Nov 2020
Study start17 Nov 2020
Primary completion17 May 2023
Study completion17 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Squamous Intraepithelial Lesions of the CervixStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: clinical trial with 2 parallel groups : 1. Treatment arm : Use of the vaginal gel for the first 6 months, then absence of treatment for the next 6 months until follow-up. * First month : 1 cannula of Papilocare® per day except the last 7 days of the month. * The next five months : alternate days except the last 7 days of the month. 2. Control arm - Absence of treatment for 12 months. Inclusion of 150 patients, balanced randomization meaning 75 patients in each arm. Follow-up after 6 months : a cervical cytology and a HPV testing for each patient + listing how many patients suffer from vaginal discomfort for 6 months. Follow-up after 12 months : a cervical cytology and a HPV testing for each patient.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04624568
Sponsor's protocol ID: CHRO-2020-13
Acronym: PAPILOCARE
Status last verified: Jun 2023
First submitted: 5 Nov 2020
Last updated: 15 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. doi: 10.1136/jcp.55.4.244.
PubMed 11919208
Ostor AG. Natural history of cervical intraepithelial neoplasia: a critical review. Int J Gynecol Pathol. 1993 Apr;12(2):186-92.
PubMed 8463044
Lousuebsakul V, Knutsen SM, Gram IT, Akin MR. Clinical impact of atypical squamous cells of undetermined significance. A cytohistologic comparison. Acta Cytol. 2000 Jan-Feb;44(1):23-30. doi: 10.1159/000326220.
PubMed 10667155
Bansal N, Wright JD, Cohen CJ, Herzog TJ. Natural history of established low grade cervical intraepithelial (CIN 1) lesions. Anticancer Res. 2008 May-Jun;28(3B):1763-6.
PubMed 18630456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With Human Papillomavirus (HPV)
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Enrolling by invitationObservational study
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
Cervical Intraepithelial Neoplasia, Cervical Neoplasms
Active, not recruiting
Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)
Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia (CIN)
Not yet recruiting
Effect of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on HPV DNA Integration
HPV Infection, HPV Integration
Not yet recruitingPhase 1/2
Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)
High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection

All Squamous Intraepithelial Lesions of the Cervix trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance.
ClinicalTrials.gov ID: NCT04624568
Acronym / sponsor ID: PAPILOCARE / CHRO-2020-13
Conditions: Squamous Intraepithelial Lesions of the Cervix, Human Papilloma Virus Infection, Cervix Lesion
Keywords: Cervical lesion, Cervical intraepithelial lesions 1, CIN1, Low grade lesion, Colposcopy, Cervical cytology, Human Papillomavirus, HPV infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Centre Hospitalier Régional d'OrléansUniversity, hospital or other
Study start: 17 Nov 2020 (actual)
Primary completion: 17 May 2023 (actual)
Study completion: 17 May 2023 (actual)
First posted: 12 Nov 2020 (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.

Detailed description

Patients will visit the Orleans hospital once for the inclusion and twice for follow-ups after 6 months and 12 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: clinical trial with 2 parallel groups : 1. Treatment arm : Use of the vaginal gel for the first 6 months, then absence of treatment for the next 6 months until follow-up. * First month : 1 cannula of Papilocare® per day except the last 7 days of the month. * The next five months : alternate days except the last 7 days of the month. 2. Control arm - Absence of treatment for 12 months. Inclusion of 150 patients, balanced randomization meaning 75 patients in each arm. Follow-up after 6 months : a cervical cytology and a HPV testing for each patient + listing how many patients suffer from vaginal discomfort for 6 months. Follow-up after 12 months : a cervical cytology and a HPV testing for each patient.

Arm	Type	Receives
Papilocare group	Experimental	Device: PAPILOCAREPapilocare® for 6 months according to the following schedule: 1 self-applying single dose per day for 21 days over 28 during the first month, then 1 day over 2 during the following 5 months, with a 7-day break during the menstrual period. (This break must be respected even in menopausal women or women undergoing artificial amenorrhea (amenorrhea induced by certain contraceptives: implant, hormonal IUD, micro-progestogen).
Control group	No intervention	–No treatment for 12 months. Smear and HPV test will be perform by all patients at 6 and 12 months

Who may qualify

Ages: 25 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Women aged 25 years old or older.
With histologically-confirmed cervical intraepithelial lesion 1 only, proven by colposcopy biopsy, done in the most suspiscious area.
With complete colposcopy, performed less than 3 months prior the inclusion
With confirmed ASC-US or LSIL cervical-cytology, performed less than 6 months prior the colposcopy.

Key exclusion criteria (10 listed)

Women under guardianship or curatorship
Women under the protection of justice
Women not affiliated with a social security system
Pregnant woman (as vaginal gel has not been evaluated in pregnant women) Urinary dosing of BHCG will be performed on the day of inclusion for all women under 55 years of age and effective contraception is recommended during the study for all non-menopausal women.
Immunodepressed women (HIV, immunosuppressive treatments ...)

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
PAPILOCAREPapilocare® is a self-administered vaginal gel. Its single-dose cannula contains hyaluronic acid and pre-biotics (Coriolus Versicolor) that would improve the re-epithelialization of the uterin cervix. By creating a protective film on the cervix, this gel could induce a favorable environment for regression of the cervical intraepithelial lesions 1 and for clearance of Human Papillomavirus. The specific approach related to our study would be to apply Papilocare® vaginal gel for 6 months for the treated group. Smear and HPV test will be perform by all patients at 6 and 12 months.	Device	Papilocare group

Primary outcome

Cervical cytology normalization after 12 months.
Time frame: Month 12
Compare the normalization rate of the cervical cytology in each arm after 12 months. The difference will be considered statistically significant if the treatment group has a normalization rate of 25% or higher. An "unsatisfactory" smear in its realization will have to be repeated within 45 days.

4 secondary outcomes

Cervical cytology normalization after 6 months.
Time frame: Month 6
HPV clearance after 6 months
Time frame: Month 6
HPV clearance after 12 months
Time frame: Month 12
Evaluation of tolerance of Papilocare vaginal gel
Time frame: Month 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Background: PubMed 11919208Bosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. doi: 10.1136/jcp.55.4.244.
Background: PubMed 8463044Ostor AG. Natural history of cervical intraepithelial neoplasia: a critical review. Int J Gynecol Pathol. 1993 Apr;12(2):186-92.
Background: PubMed 10667155Lousuebsakul V, Knutsen SM, Gram IT, Akin MR. Clinical impact of atypical squamous cells of undetermined significance. A cytohistologic comparison. Acta Cytol. 2000 Jan-Feb;44(1):23-30. doi: 10.1159/000326220.
Results publication: PubMed 18630456Bansal N, Wright JD, Cohen CJ, Herzog TJ. Natural history of established low grade cervical intraepithelial (CIN 1) lesions. Anticancer Res. 2008 May-Jun;28(3B):1763-6.

Related trials for Squamous Intraepithelial Lesions of the Cervix

Not yet recruiting
Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With Human Papillomavirus (HPV)
Human Papillomavirus Infection, Human Papillomavirus Infections
Enrolling by invitationObservational study
Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
Cervical Intraepithelial Neoplasia, Cervical Neoplasms
Active, not recruiting
Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)
Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia (CIN)
Not yet recruiting
Effect of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on HPV DNA Integration
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Not yet recruitingPhase 1/2
Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)
High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection

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.

Helene GBAGUIDI, Dr principal investigator

CHR ORLEANS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PAPILOCARE in people with Squamous Intraepithelial Lesions of the Cervix and Human Papilloma Virus Infection, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

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 4 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jun 2023. 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 France. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cervical cytology normalization after 12 months. (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624568, which also lists 4 linked publications.

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 15 Jun 2023.