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

NCT ID: NCT04199078

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2024-06-30

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.

Detailed Description

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) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (Papilocare schedule C) Arm D (usual clinical practice-without treatment-).

Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment.

Patients will visit the site into a total of 5 visits throughout the study. Total study duration: 13 months.

Conditions

Human Papilloma Virus; Human Papilloma Virus Infection; Cervix Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A - papilocare alternative days treatment

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)

Group Type: EXPERIMENTAL

Papilocare vaginal gel

Intervention Type: 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

B - papilocare semiintensive treatment

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)

Group Type: EXPERIMENTAL

Papilocare vaginal gel

Intervention Type: 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

C - papilocare intensive treatment

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

Group Type: EXPERIMENTAL

Papilocare vaginal gel

Intervention Type: 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

D - standard of care

Arm D: usual clinical practice - no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Papilocare vaginal gel

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Woman between the ages of 30 and 65 (both inclusive).

2. Able to read and understand the Patient Information Sheet and the Informed Consent form.

3. Acceptance in the participation of the essay and signature of the Informed Consent form.

4. ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit).

5. High risk HPV positive by PCR performed at screening visit.

6. 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.

Exclusion Criteria

1. Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.

2. Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).

3. To had been vaccinated against HPV.

4. Other symptomatic vulvovaginal infections.

5. Surgical cervical excision in the last year or total hysterectomy.

6. Previous history of gynecological cancer.

7. Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial.

8. Any planned surgery that prevents the correct compliance with the guidelines.

9. Use of vaginal contraceptives or other vaginal hormonal treatments.

10. Contraindications for the use of Papilocare® gel or known allergies to any of its components.

11. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Adknoma Health Research

INDUSTRY

Sponsor Role: collaborator

Procare Health Iberia S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Cortes Bordoy, MD

Role: STUDY_CHAIR

AEPCC

Locations

Hospital U. de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Complejo Hospitalario Torrecárdenas

Almería, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitari Vall d' Hebron

Barcelona, , Spain

Hospital de Basurto

Bilbao, , Spain

H. U. Reina Sofía

Córdoba, , Spain

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Assir Hospitalet de Llobregat

L'Hospitalet de Llobregat, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital de Manacor

Manacor, , Spain

H. R. U. de Málaga / Materno Infantil

Málaga, , Spain

H. General Universitario Santa Lucía

Murcia, , Spain

Hospital Virgen de la Macarena

Seville, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Hospital Álvaro Cunqueiro

Vigo, , Spain

Countries

Spain

Other Identifiers

PALOMA II

Identifier Type: -

Identifier Source: org_study_id