Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV (PAPILOCAN)

January 26, 2023 updated by: Procare Health Iberia S.L.

Estudio clínico, Aleatorizado, Doble Ciego, Paralelo, Controlado Con Placebo Para Evaluar la Eficacia Del Gel Papilocare® en la reparación de Lesiones Cervicales Causadas Por VPH. Randomized, Double-blind, Parallel, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Papilocare® Gel in the Repairment of Cervical Lesions Caused by HPV.

Clinical Trial phase III, randomized, double-blind, placebo-controlled and parallel-group clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.

The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or placebo, using a randomization list and in double-blind conditions.

Study Overview

Status

Completed

Detailed Description

Phase III, randomized, double-blind, placebo-controlled and parallel-group clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.

The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or placebo, using a randomization list and in double-blind conditions.

The study is divided into 2 parts, the first 100 randomized patients will receive treatment with an administration regimen in both arms: 1 cannula / day for 1 month + 1 cannula on alternate days for 5 months (except for menstruation days). The second part of the study, randomized patients from position 101 to 200, will receive treatment with an administration regimen in both arms: 1 cannula / day for 3 months + 1 cannula on alternate days for 3 months (except the days of menstruation).

Duration of treatment: 6 months Total study duration: 13 months in 5 visits: selection visit, V0 or randomization visit (30 days), V1(Month 3), V2 (Month 6), V3 (Month 12).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Senora de la Candelaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Woman between the ages of 30 and 65 (both included).
  2. Able to read and understand the Patient Information Sheet and informed consent
  3. Accept participation in the study and sign the Informed Consent.
  4. Cytological result of ASC-US or LSIL, with concordant colposcopic image, at most 3 months before the selection visit. It is considered concordant with ASCUS and LSIL, a colposcopic result of normality, of non-specific findings or of type 1 changes.
  5. Positive HPV according to cobas 4800 technique (high-risk HPV) carried out in a selection visit (or positive available at most 3 months prior to the baseline visit).
  6. Women vaccinated and not vaccinated against HPV.
  7. Is able, at the discretion of the researcher, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout it.

Exclusion Criteria:

  1. Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
  2. Other cytological results other than those provided for in the inclusion criteria.
  3. Baseline LSIL biopsies with CIN-3.
  4. Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit)
  5. Other symptomatic vulvovaginal infections.
  6. Surgical cervical excision in the last year or total hysterectomy.
  7. Previous history of gynecological cancer.
  8. Participation in any other clinical trial at present or in the 4 weeks prior to inclusion of the study.
  9. Any planned surgery that precludes correct compliance with the guideline.
  10. Use of vaginal contraceptives or other vaginal hormonal treatments.
  11. Contraindications to the use of Papilocare® gel or known allergies to any of its components.
  12. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspected pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAPILOCARE

Randomized patients will receive two different guidelines depending on the time of randomization:

  • Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ).
  • Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) .

Papilocare®: Vaginal Gel based on Coriolus versicolor, medical device class IIa.

Route of administration: topical (vaginal). Papilocare® consists of the following ingredients: hyaluronic acid niosomes, β-glucans (magnolol, honokiol and carboxymethyl betaglucan) niosomes, BioEcolia® (Alpha-oligoglycan), Coriolus versicolor, Azadirachta indica (Neem) extract, Centella asiatica and Aloe vera.

Placebo Comparator: PLACEBO

Randomized patients will receive two different guidelines depending on the time of randomization:

  • Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ).
  • Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) .
The placebo consists of a carrier gel with the absence of the active ingredients of Papilocare®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cervical mucosal repair
Time Frame: 6 months
Percentage of patients with cervical lesions negativization confirmed be cytology and accordance colposcopy , at 6 months will be used to evaluate the main variables, degree of cervical mucosal repair in HPV-positive women with ASC-US or LSIL.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reepithelialization degree of the cervical mucosa
Time Frame: at 3 months
Percentage of patients with negativity of cervical lesions by cytology and accordance colposcopy, at 3 months
at 3 months
Percentage of patients with Viral clearance
Time Frame: 3 and 6 months.
Percentage of patients with initial HPV clearance measured by PCR at 3 and 6 months.
3 and 6 months.
Vaginal health status measured by vaginal health index (VHI)
Time Frame: 3 and 6 months.

Changes in the VHI (vaginal health index -Bachmann) at 3 and 6 months.

VHI was developed in order to objectively assess female urogenital health (Bachmann GMaturitas. 1995 Dec; 22 Suppl():S1-S5.). This test evaluates overall elasticity, fluid secretion type and consistency, vaginal pH, epithelial mucosa and moisture. Minimum score is 5 and maximum is 25. Lower scores corresponds to greater urogenital atrophy.

3 and 6 months.
Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
Time Frame: 3 and 6 months.

Changes PSS-14 scale (Perceived Stress Scale 14 items) at 3 and 6 months.

The PSS-14 is comprised of 14 items, score ranges from 0-56, with higher scores indicating greater perceived stress

3 and 6 months.
Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
Time Frame: 6 months
Record of the incidence, nature and severity of adverse events: during the 6 months of treatment duration.
6 months
Satisfaction degree with Papilocare gel use: Likert type scale
Time Frame: 3 and 6 months.

Patients satisfaction degree with papilocare gel use as treatment will be evaluated by a likert type scale.

A Likert scale is a psychometric scale commonly involved in research that employs questionnaires. It is the most widely used approach to scaling responses in survey research.Likert scaling assumes distances between each choice (answer option) are equal. Higher scores corresponds to better satisfaction with papilocare gel use.

3 and 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of biopsy results (optional)
Time Frame: 3 and 6 months.
Only in cases that a biopsy has been performed per routine, the change or maintenance of biopsy results will be evaluated.
3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alfonso Quesada López-Fe, Doctor, H Nuestra Señora de la Candelaria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PAPILOCAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The PI from the participant site received the study protocol and the informed consent form previously to the initiation of the study and every time it occurs an amendment over the protocol, ICF or any other study document. Once the study will finish and the data will be analyzed, the PI will receive the CSR.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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