Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. (PALOMA2)

Procare Health

Status: Completed

Conditions: Human Papilloma Virus; Human Papilloma Virus Infection; Cervix Lesion

Treatments: Device: Papilocare vaginal gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04199078

PALOMA II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 4 patient groups

A - papilocare alternative days treatment

Experimental group

Description:

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)

Treatment:

Device: Papilocare vaginal gel

B - papilocare semiintensive treatment

Experimental group

Description:

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)

Treatment:

Device: Papilocare vaginal gel

C - papilocare intensive treatment

Experimental group

Description:

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

Treatment:

Device: Papilocare vaginal gel

D - standard of care

No Intervention group

Description:

Arm D: usual clinical practice - no treatment