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

NCT04624568 | Completed

• 1 other identifier: CHRO-2020-13
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

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; HPV testing; Vaginal gel; Papilocare®

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 12

Secondary Outcomes (4)

• Cervical cytology normalization after 6 months.

  Month 6

• HPV clearance after 6 months

  Month 6

• HPV clearance after 12 months

  Month 12

• Evaluation of tolerance of Papilocare vaginal gel

  Month 6

Study Arms (2)

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).

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

Interventions

PAPILOCARE DEVICE

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.

Papilocare group

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 confirmed ASC-US or LSIL cervical-cytology, performed less than 6 months prior the colposcopy.

You may not qualify if:

• Women under guardianship or curatorship
• Women under the protection of justice
• Women not affiliated with a social security system
• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Régional d'Orléans, France

Orléans, 45000, France

Location

Related Publications (4)

• 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.

  PMID: 11919208 BACKGROUND

• Ostor AG. Natural history of cervical intraepithelial neoplasia: a critical review. Int J Gynecol Pathol. 1993 Apr;12(2):186-92.

  PMID: 8463044 BACKGROUND

• 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.

  PMID: 10667155 BACKGROUND

• 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.

  PMID: 18630456 RESULT

MeSH Terms

Conditions

Squamous Intraepithelial Lesions of the Cervix; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Squamous Intraepithelial Lesions; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes

Study Officials

• Helene GBAGUIDI, Dr

  CHR ORLEANS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: November 17, 2020
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

FR (1)