Clinical trial NCT04199078: Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
Official title: Ensayo clínico Aleatorizado, Abierto, Paralelo, Controlado, multicéntrico, Para Explorar la Eficacia Del Gel Vaginal Papilocare® en la reparación de la Mucosa Cervical Con Lesiones Causadas Por Virus Papiloma Humano de Alto Riesgo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Human Papilloma Virus Infection
Cervix Lesion
Keywords: HPV
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
Collaborators: name: Adknoma Health Research
First posted: 2019-12-13
Enrollment: 288
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
timeFrame: 3 and 12 months
measure: Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale
timeFrame: 3,6 and 12 months
measure: Presence of HPV at 6 and 12 months after starting treatment.
timeFrame: 6 and 12 months]
measure: Evaluation of vaginal health status by vaginal health index score (Bachmann)
timeFrame: 3,6 and 12 months]
measure: To evaluate the safety and tolerability of Papilocare® gel during the 6 months of treatment and 6 months of follow-up.
timeFrame: 6 and 12 months]
measure: To assess the stress received from the patients at 3, 6 and 12 months after starting treatment.
timeFrame: 3,6 and 12 months]
measure: Evaluation of the satisfaction of papilocare gel use by a likert-type scale
timeFrame: 3 and 6 months]
measure: Percentage of patients with good therapeutic compliance
timeFrame: 3 and 6 months]
Other outcomes:
Locations:
city: Donostia
country: Spain
facility: Hospital U. de Donostia
state: Guipuzcoa
city: Móstoles
country: Spain
facility: Hospital Universitario HM Puerta del Sur
state: Madrid
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Mallorca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
state: Tenerife
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Almeria
country: Spain
facility: Complejo Hospitalario Torrecárdenas
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebron
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Córdoba
country: Spain
facility: H. U. Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Hospitalet de Llobregat
country: Spain
facility: Assir Hospitalet de Llobregat
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Manacor
country: Spain
facility: Hospital de Manacor
city: Murcia
country: Spain
facility: H. General Universitario Santa Lucía
city: Málaga
country: Spain
facility: H. R. U. de Málaga / Materno Infantil
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: AEPCC
name: Javier Cortes Bordoy, MD
role: STUDY_CHAIR
References: