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

Primary Purpose

HPV Infection, Lesion Cervix

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PAPILOCARE
PLACEBO
Sponsored by
Procare Health Iberia S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HPV Infection

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Nuestra Señora de la Candelaria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PAPILOCARE

PLACEBO

Arm Description

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) .

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) .

Outcomes

Primary Outcome Measures

cervical mucosal repair
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.

Secondary Outcome Measures

Reepithelialization degree of the cervical mucosa
Percentage of patients with negativity of cervical lesions by cytology and accordance colposcopy, at 3 months
Percentage of patients with Viral clearance
Percentage of patients with initial HPV clearance measured by PCR at 3 and 6 months.
Vaginal health status measured by vaginal health index (VHI)
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.
Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
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
Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
Record of the incidence, nature and severity of adverse events: during the 6 months of treatment duration.
Satisfaction degree with Papilocare gel use: Likert type scale
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.

Full Information

First Posted
December 11, 2019
Last Updated
January 26, 2023
Sponsor
Procare Health Iberia S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04210336
Brief Title
Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV
Acronym
PAPILOCAN
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procare Health Iberia S.L.

4. Oversight

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

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection, Lesion Cervix

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAPILOCARE
Arm Type
Experimental
Arm Description
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) .
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
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) .
Intervention Type
Device
Intervention Name(s)
PAPILOCARE
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PLACEBO
Intervention Description
The placebo consists of a carrier gel with the absence of the active ingredients of Papilocare®.
Primary Outcome Measure Information:
Title
cervical mucosal repair
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reepithelialization degree of the cervical mucosa
Description
Percentage of patients with negativity of cervical lesions by cytology and accordance colposcopy, at 3 months
Time Frame
at 3 months
Title
Percentage of patients with Viral clearance
Description
Percentage of patients with initial HPV clearance measured by PCR at 3 and 6 months.
Time Frame
3 and 6 months.
Title
Vaginal health status measured by vaginal health index (VHI)
Description
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.
Time Frame
3 and 6 months.
Title
Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
Description
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
Time Frame
3 and 6 months.
Title
Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
Description
Record of the incidence, nature and severity of adverse events: during the 6 months of treatment duration.
Time Frame
6 months
Title
Satisfaction degree with Papilocare gel use: Likert type scale
Description
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.
Time Frame
3 and 6 months.
Other Pre-specified Outcome Measures:
Title
Change of biopsy results (optional)
Description
Only in cases that a biopsy has been performed per routine, the change or maintenance of biopsy results will be evaluated.
Time Frame
3 and 6 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman between the ages of 30 and 65 (both included). Able to read and understand the Patient Information Sheet and informed consent Accept participation in the study and sign the Informed Consent. 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. 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). Women vaccinated and not vaccinated against HPV. 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: Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants. Other cytological results other than those provided for in the inclusion criteria. Baseline LSIL biopsies with CIN-3. Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit) Other symptomatic vulvovaginal infections. Surgical cervical excision in the last year or total hysterectomy. Previous history of gynecological cancer. Participation in any other clinical trial at present or in the 4 weeks prior to inclusion of the study. Any planned surgery that precludes correct compliance with the guideline. Use of vaginal contraceptives or other vaginal hormonal treatments. Contraindications to the use of Papilocare® gel or known allergies to any of its components. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspected pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Quesada López-Fe, Doctor
Organizational Affiliation
H Nuestra Señora de la Candelaria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Nuestra Señora de la Candelaria
City
Santa Cruz de Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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