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

Primary Purpose

Squamous Intraepithelial Lesions of the Cervix, Human Papilloma Virus Infection, Cervix Lesion

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PAPILOCARE
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Intraepithelial Lesions of the Cervix focused on measuring Cervical lesion, Cervical intraepithelial lesions 1, CIN1, Low grade lesion, Colposcopy, Cervical cytology, Human Papillomavirus, HPV infection, HPV testing, Vaginal gel, Papilocare®

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Centre Hospitalier Régional d'Orléans, France

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Papilocare group

Control group

Arm Description

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).

No treatment for 12 months. Smear and HPV test will be perform by all patients at 6 and 12 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cervical cytology normalization after 6 months.
Compare the normalization rate of the cervical cytology in each arm after 6 months.
HPV clearance after 6 months
2) 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.
HPV clearance after 12 months
2) 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.
Evaluation of tolerance of Papilocare vaginal gel
Compare in each group the number of episodes of vaginal discomfort over the first 6 months.

Full Information

First Posted
November 5, 2020
Last Updated
June 14, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT04624568
Brief Title
Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance
Acronym
PAPILOCARE
Official Title
Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
May 17, 2023 (Actual)
Study Completion Date
May 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, HPV testing, Vaginal gel, Papilocare®

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clinical trial with 2 parallel groups : 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. 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
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Papilocare group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No treatment for 12 months. Smear and HPV test will be perform by all patients at 6 and 12 months
Intervention Type
Device
Intervention Name(s)
PAPILOCARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cervical cytology normalization after 12 months.
Description
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.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Cervical cytology normalization after 6 months.
Description
Compare the normalization rate of the cervical cytology in each arm after 6 months.
Time Frame
Month 6
Title
HPV clearance after 6 months
Description
2) 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.
Time Frame
Month 6
Title
HPV clearance after 12 months
Description
2) 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.
Time Frame
Month 12
Title
Evaluation of tolerance of Papilocare vaginal gel
Description
Compare in each group the number of episodes of vaginal discomfort over the first 6 months.
Time Frame
Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene GBAGUIDI, Dr
Organizational Affiliation
CHR ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional d'Orléans, France
City
Orléans
ZIP/Postal Code
45000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11919208
Citation
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.
Results Reference
background
PubMed Identifier
8463044
Citation
Ostor AG. Natural history of cervical intraepithelial neoplasia: a critical review. Int J Gynecol Pathol. 1993 Apr;12(2):186-92.
Results Reference
background
PubMed Identifier
10667155
Citation
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.
Results Reference
background
PubMed Identifier
18630456
Citation
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.
Results Reference
result

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

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