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

NCT04210336 | Completed

• 1 other identifier: PAPILOCAN
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Trial phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel 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 lactic acid gel, using a randomization list and in double-blind conditions.

Conditions

HPV Infection; Lesion Cervix

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Reepithelialization degree of the cervical mucosa

  at 3 months

• Percentage of patients with Viral clearance

  3 and 6 months.

• Vaginal health status measured by vaginal health index (VHI)

  3 and 6 months.

• Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)

  3 and 6 months.

• Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events

  6 months

Other Outcomes (1)

• Change of biopsy results (optional)

  3 and 6 months.

Study Arms (2)

PAPILOCARE

EXPERIMENTAL

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) .

Device: PAPILOCARE

LACTIC ACID GEL

ACTIVE COMPARATOR

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) .

Device: LACTIC ACID GEL

Interventions

PAPILOCARE DEVICE

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.

PAPILOCARE

LACTIC ACID GEL DEVICE

The lactic acid gel consists of a carrier gel with the absence of the active ingredients of Papilocare®.

LACTIC ACID GEL

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
• 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.
• 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.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead

Study Sites (1)

Hospital Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfonso Quesada López-Fe, Doctor

  H Nuestra Señora de la Candelaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 24, 2019
• Study Start: August 7, 2018
• Primary Completion: November 30, 2022
• Study Completion: January 20, 2023
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

ES (1)