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

Not Applicable

Completed

• Conditions: Human Papilloma Virus; Human Papilloma Virus Infection; Cervix Lesion
• Interventions: Device: Papilocare vaginal gel

• Registration Number: NCT04199078
• Lead Sponsor: Procare Health Iberia S.L.

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.

Study Timeline

• Study Start: 2019-09-25
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Primary Completion: 2024-01-31
• Study Completion: 2024-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 288

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - papilocare alternative days treatment	Papilocare vaginal gel	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)
C - papilocare intensive treatment	Papilocare vaginal gel	Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months
B - papilocare semiintensive treatment	Papilocare vaginal gel	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)

Primary Outcome Measures

Name	Time	Method
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Presence of HPV at 6 and 12 months after starting treatment.	6 and 12 months]	Percentage of patients with total and partial clearance of HPV measured by genotyping PCR at 6 and 12 months after starting treatment.
To assess the stress received from the patients at 3, 6 and 12 months after starting treatment.	3,6 and 12 months]	The stress will be assessed on the PSS14 scale (Perceived Stress Scale 14 items) at 3, 6 and 12 months after the starting treatment.
Percentage of patients with good therapeutic compliance	3 and 6 months]	Percentage of patients with good adherence to the treatment will be used to evaluate the therapeutic compliance at 3 and 6 months after the start of treatment.
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image	3 and 12 months	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 at 3 and 12 months after the start of treatment.
Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale	3,6 and 12 months	A likert-type scale will be used to evaluate the reeptielization degree of the cervico-vaginal mucosa at 3, 6 and 12 months after the start of treatment.
Evaluation of the satisfaction of papilocare gel use by a likert-type scale	3 and 6 months]	A likert-type scale will be used to evaluate the satisfaction of papilocare gel use by the patients at 3 and 6 months after the start of treat
Evaluation of vaginal health status by vaginal health index score (Bachmann)	3,6 and 12 months]	The vaginal health index score (Bachmann) will be used to evaluate vaginal health status at 3, 6 and 12 months from the start of treatment
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]	Safety and tolerability: incidence, nature and severity of adverse events at 6 months of treatment and 6 months of follow-up period.

Trial Locations

Locations (19)

H. R. U. de Málaga / Materno Infantil; 🇪🇸 Málaga, Spain

Hospital Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario Nuestra Señora de Candelaria; 🇪🇸 Santa Cruz De Tenerife, Tenerife, Spain

Hospital Universitari Vall d' Hebron; 🇪🇸 Barcelona, Spain

Hospital U. de Donostia; 🇪🇸 Donostia, Guipuzcoa, Spain

Assir Hospitalet de Llobregat; 🇪🇸 Hospitalet de Llobregat, Spain

H. U. Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital de Manacor; 🇪🇸 Manacor, Spain

Complejo Hospitalario Torrecárdenas; 🇪🇸 Almeria, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario HM Puerta del Sur; 🇪🇸 Móstoles, Madrid, Spain

Hospital Universitari Son Espases; 🇪🇸 Palma De Mallorca, Mallorca, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

H. General Universitario Santa Lucía; 🇪🇸 Murcia, Spain

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain