Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.

NCT04199078 | Completed

• 1 other identifier: PALOMA II
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 19

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-HR. All the patients included in the study will be randomized (1:1:1:1) in 4 arms.

Conditions

Human Papilloma Virus; Human Papilloma Virus Infection; Cervix Lesion

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image

  Evaluate the repairment of the cervico-vaginal mucosa in positive high risk 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 (8)

• Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image

  3 and 12 months

• Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale

  3,6 and 12 months

• Presence of HPV at 6 and 12 months after starting treatment.

  6 and 12 months]

• Evaluation of vaginal health status by vaginal health index score (Bachmann)

  3,6 and 12 months]

• To evaluate the safety and tolerability of Papilocare® gel during the 6 months of treatment and 6 months of follow-up.

  6 and 12 months]

Study Arms (4)

A - papilocare alternative days treatment

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 treatment

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 - papilocare intensive treatment

EXPERIMENTAL

Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months

Device: Papilocare vaginal gel

D - standard of care

NO INTERVENTION

Arm D: usual clinical practice - no treatment

Interventions

Papilocare vaginal gel DEVICE

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

A - papilocare alternative days treatment; B - papilocare semiintensive treatment; C - papilocare intensive treatment

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 inclusive).
• Able to read and understand the Patient Information Sheet and the Informed Consent form.
• Acceptance in the participation of the essay and signature of the Informed Consent form.
• High risk HPV positive by PCR performed at screening visit.
• Is able, at the discretion of the researcher, to comply with the requirements of the trial and without hindrance to follow the instructions and assessments 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 guidelines.
• Use of vaginal contraceptives or other vaginal hormonal treatments.
• Contraindications for 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 suspicion of pregnancy or woman who are breastfeeding.

Sponsors & Collaborators

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

Study Sites (19)

Hospital U. de Donostia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Complejo Hospitalario Torrecárdenas

Almería, 04009, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, 08035, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

H. U. Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Assir Hospitalet de Llobregat

L'Hospitalet de Llobregat, 08904, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital de Manacor

Manacor, Spain

Location

H. R. U. de Málaga / Materno Infantil

Málaga, 29010, Spain

Location

H. General Universitario Santa Lucía

Murcia, 30202, Spain

Location

Hospital Virgen de la Macarena

Seville, 41009, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, 36312, 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

• Javier Cortes Bordoy, MD

  AEPCC

  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: December 11, 2019
• First Posted: December 13, 2019
• Study Start: September 25, 2019
• Primary Completion: January 31, 2024
• Study Completion: June 30, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

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

Locations

ES (19)