Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV

NCT04002154 | Completed

• 1 other identifier: PHPC-201501
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 9

Brief Summary

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1).

Conditions

Human Papilloma Virus Infection; Human Papilloma Virus; Cervix Lesion

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image

  Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image, 6 months after the start of treatment.

  6 months

Secondary Outcomes (5)

• Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image

  3 and 12 months

• Reeptielization of the cervico-vaginal mucosa measured by a likert scale.

  3,6 and 12 months

• Vaginal health status measured by Bachmann Index.

  3,6 and 12 months

• Satisfaction of papilocare gel use measured by likert scale.

  3 and 6 months

• Therapeutic compliance

  3 and 6 months

Study Arms (3)

A - papilocare alternative days

EXPERIMENTAL

Arm A: scheme A (21 days / 1 cannula per day + 7 days rest) x 1 month + alternate days up to 6 months (except for menstruation days)

Device: Papilocare vaginal gel

B - papilocare semiintensive

EXPERIMENTAL

Arm B: scheme B (21 days / 1 cannula per day + 7 days rest) x 3 months + alternate days up to 6 months (except menstruation days)

Device: Papilocare vaginal gel

C - standard of care

NO INTERVENTION

Arm C: usual clinical practice: no treatment

Interventions

Papilocare vaginal gel DEVICE

Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution

A - papilocare alternative days; B - papilocare semiintensive

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 the Informed Consent form.
• Accept participation in the study and sign the Informed Consent form.
• Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
• Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
• Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations throughout it.

You may not qualify if:

• Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
• Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
• To had been vaccinated against HPV.
• Other symptomatic vulvovaginal infections.
• Surgical cervical excision in the last year or total hysterectomy.
• Previous history of gynecological cancer.
• Any planned surgery that prevents the correct compliance with the protocol.
• Use of vaginal contraceptives or other vaginal hormonal treatments.
• Contraindications for Papilocare gel use or known allergies to any of its components.
• Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead
• Adknoma Health Research: collaborator

Study Sites (9)

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Clínica Diatros - TEKNON

Barcelona, 08017, Spain

Location

Women´s Health Institute

Barcelona, 08017, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Gabinete Médico Velázquez

Madrid, 28001, Spain

Location

Hospital Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, 41720, Spain

Location

Hospital Quirón Málaga

Málaga, 29004, Spain

Location

Related Publications (1)

• 2021 ASCCP Poster Presentations. J Low Genit Tract Dis. 2021 Apr 1;25(2S):9-11. doi: 10.1097/LGT.0000000000000602. No abstract available.

  PMID: 33743523 DERIVED

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

• Javier Cortés Bordoy, MD

  Hospital os Palma de Mallorca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 28, 2019
• Study Start: October 19, 2015
• Primary Completion: July 31, 2018
• Study Completion: February 28, 2019
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

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

Locations

ES (9)