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

Human Papilloma Virus Clinical Trial

— PALOMA2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04199078
• Other study ID #: PALOMA II
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Procare Health Iberia S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 288
• Est. completion date: June 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervix Lesion
• Human Papilloma Virus
• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Complejo Hospitalario Torrecárdenas	Almeria
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 U. de Donostia	Donostia	Guipuzcoa
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Assir Hospitalet de Llobregat	Hospitalet de Llobregat
Spain	Hospital Universitario La Paz	Madrid
Spain	H. R. U. de Málaga / Materno Infantil	Málaga
Spain	Hospital de Manacor	Manacor
Spain	Hospital Universitario HM Puerta del Sur	Móstoles	Madrid
Spain	H. General Universitario Santa Lucía	Murcia
Spain	Hospital Universitari Son Espases	Palma De Mallorca	Mallorca
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife	Tenerife
Spain	Hospital Virgen de la Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (2)

Lead Sponsor	Collaborator
Procare Health Iberia S.L.	Adknoma Health Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 at 3 and 12 months after the start of treatment.	3 and 12 months
Secondary	Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale	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.	3,6 and 12 months
Secondary	Presence of HPV at 6 and 12 months after starting treatment.	Percentage of patients with total and partial clearance of HPV measured by genotyping PCR at 6 and 12 months after starting treatment.	6 and 12 months]
Secondary	Evaluation of vaginal health status by vaginal health index score (Bachmann)	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	3,6 and 12 months]
Secondary	To evaluate the safety and tolerability of Papilocare® gel during the 6 months of treatment and 6 months of follow-up.	Safety and tolerability: incidence, nature and severity of adverse events at 6 months of treatment and 6 months of follow-up period.	6 and 12 months]
Secondary	To assess the stress received from the patients at 3, 6 and 12 months after starting treatment.	The stress will be assessed on the PSS14 scale (Perceived Stress Scale 14 items) at 3, 6 and 12 months after the starting treatment.	3,6 and 12 months]
Secondary	Evaluation of the satisfaction of papilocare gel use by a likert-type scale	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	3 and 6 months]
Secondary	Percentage of patients with good therapeutic compliance	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.	3 and 6 months]