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

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

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.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus Infection; Human Papilloma Virus; Cervix Lesion
• Intervention / Treatment: Device: Papilocare vaginal gel

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 Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Almeria, Spain, 04009
    • Complejo Hospitalario Torrecárdenas
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d' Hebron
  • Bilbao, Spain, 48013
    • Hospital De Basurto
  • Córdoba, Spain, 14004
    • H. U. Reina Sofía
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Hospitalet de Llobregat, Spain, 08904
    • Assir Hospitalet de Llobregat
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Manacor, Spain
    • Hospital de Manacor
  • Murcia, Spain, 30202
    • H. General Universitario Santa Lucía
  • Málaga, Spain, 29010
    • H. R. U. de Málaga / Materno Infantil
  • Sevilla, Spain, 41009
    • Hospital Virgen De La Macarena
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Vigo, Spain, 36312
    • Hospital Álvaro Cunqueiro
  • Guipuzcoa
    • Donostia, Guipuzcoa, Spain, 20014
      • Hospital U. de Donostia
  • Madrid
    • Móstoles, Madrid, Spain, 28938
      • Hospital Universitario HM Puerta del Sur
  • Mallorca
    • Palma De Mallorca, Mallorca, Spain, 07120
      • Hospital Universitari Son Espases
  • Tenerife
    • Santa Cruz De Tenerife, Tenerife, Spain, 38010
      • Hospital Universitario Nuestra Señora de Candelaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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
Experimental: 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)	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
Experimental: C - papilocare intensive treatment; Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months	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
No Intervention: D - standard of care; Arm D: usual clinical practice - no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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]
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]
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]
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]
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]
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]

Collaborators and Investigators

• Sponsor: Procare Health Iberia S.L.
• Collaborators: Adknoma Health Research
• Investigators: Study Chair: Javier Cortes Bordoy, MD, AEPCC

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: HPV
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Infections; Virus Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Neoplasms, Squamous Cell; Tumor Virus Infections; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: PALOMA II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PIs from the participant sites gonna received the study protocol and the informed consent form previously to the initiation of the study and every time it occurs an amendment over the protocol, ICF or any other study document. Once the study has finished and the data has been analyzed, the PI's from the sites gonna received the CSR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No