Back to resultsClinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. (PALOMA2)
Primary Purpose
Human Papilloma Virus, Human Papilloma Virus Infection, Cervix Lesion
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Papilocare vaginal gel
Sponsored by
About this trial
This is an interventional treatment trial for Human Papilloma Virus focused on measuring HPV
Eligibility Criteria
Inclusion Criteria:
- Woman between the ages of 30 and 65 (both inclusive).
- Able to read and understand the Patient Information Sheet and the Informed Consent form.
- Acceptance in the participation of the essay and signature of the Informed Consent form.
- ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit).
- High risk HPV positive by PCR performed at screening visit.
- 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:
- Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
- Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
- To had been vaccinated against HPV.
- Other symptomatic vulvovaginal infections.
- Surgical cervical excision in the last year or total hysterectomy.
- Previous history of gynecological cancer.
- Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial.
- Any planned surgery that prevents the correct compliance with the guidelines.
- Use of vaginal contraceptives or other vaginal hormonal treatments.
- Contraindications for the use of Papilocare® gel or known allergies to any of its components.
- Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.
Sites / Locations
- Hospital U. de Donostia
- Hospital Universitario HM Puerta del Sur
- Hospital Universitari Son Espases
- Hospital Universitario Nuestra Señora de Candelaria
- Hospital General Universitario de Alicante
- Complejo Hospitalario Torrecárdenas
- Hospital del Mar
- Hospital Universitari Vall d' Hebron
- Hospital de Basurto
- H. U. Reina Sofía
- Hospital Universitario Virgen de las Nieves
- Assir Hospitalet de Llobregat
- Hospital Universitario La Paz
- Hospital de Manacor
- H. General Universitario Santa Lucía
- H. R. U. de Málaga / Materno Infantil
- Hospital Virgen de la Macarena
- Hospital Universitari i Politecnic La Fe
- Hospital Álvaro Cunqueiro
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
A - papilocare alternative days treatment
B - papilocare semiintensive treatment
C - papilocare intensive treatment
D - standard of care
Arm 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)
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)
Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months
Arm D: usual clinical practice - no treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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.
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.
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
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.
Full Information
NCT ID
NCT04199078
First Posted
December 11, 2019
Last Updated
January 26, 2023
Sponsor
Procare Health Iberia S.L.
Collaborators
Adknoma Health Research
1. Study Identification
Unique Protocol Identification Number
NCT04199078
Brief Title
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procare Health Iberia S.L.
Collaborators
Adknoma Health Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus, Human Papilloma Virus Infection, Cervix Lesion
Keywords
HPV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A - papilocare alternative days treatment
Arm Type
Experimental
Arm 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)
Arm Title
B - papilocare semiintensive treatment
Arm Type
Experimental
Arm 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)
Arm Title
C - papilocare intensive treatment
Arm Type
Experimental
Arm Description
Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months
Arm Title
D - standard of care
Arm Type
No Intervention
Arm Description
Arm D: usual clinical practice - no treatment
Intervention Type
Device
Intervention Name(s)
Papilocare vaginal gel
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Description
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.
Time Frame
3 and 12 months
Title
Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale
Description
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.
Time Frame
3,6 and 12 months
Title
Presence of HPV at 6 and 12 months after starting treatment.
Description
Percentage of patients with total and partial clearance of HPV measured by genotyping PCR at 6 and 12 months after starting treatment.
Time Frame
6 and 12 months]
Title
Evaluation of vaginal health status by vaginal health index score (Bachmann)
Description
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
Time Frame
3,6 and 12 months]
Title
To evaluate the safety and tolerability of Papilocare® gel during the 6 months of treatment and 6 months of follow-up.
Description
Safety and tolerability: incidence, nature and severity of adverse events at 6 months of treatment and 6 months of follow-up period.
Time Frame
6 and 12 months]
Title
To assess the stress received from the patients at 3, 6 and 12 months after starting treatment.
Description
The stress will be assessed on the PSS14 scale (Perceived Stress Scale 14 items) at 3, 6 and 12 months after the starting treatment.
Time Frame
3,6 and 12 months]
Title
Evaluation of the satisfaction of papilocare gel use by a likert-type scale
Description
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
Time Frame
3 and 6 months]
Title
Percentage of patients with good therapeutic compliance
Description
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.
Time Frame
3 and 6 months]
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Woman between the ages of 30 and 65 (both inclusive).
Able to read and understand the Patient Information Sheet and the Informed Consent form.
Acceptance in the participation of the essay and signature of the Informed Consent form.
ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit).
High risk HPV positive by PCR performed at screening visit.
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:
Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
To had been vaccinated against HPV.
Other symptomatic vulvovaginal infections.
Surgical cervical excision in the last year or total hysterectomy.
Previous history of gynecological cancer.
Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial.
Any planned surgery that prevents the correct compliance with the guidelines.
Use of vaginal contraceptives or other vaginal hormonal treatments.
Contraindications for the use of Papilocare® gel or known allergies to any of its components.
Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Cortes Bordoy, MD
Organizational Affiliation
AEPCC
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital U. de Donostia
City
Donostia
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universitario HM Puerta del Sur
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma De Mallorca
State/Province
Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital Universitario Nuestra Señora de Candelaria
City
Santa Cruz De Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Complejo Hospitalario Torrecárdenas
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d' Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
H. U. Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Assir Hospitalet de Llobregat
City
Hospitalet de Llobregat
ZIP/Postal Code
08904
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital de Manacor
City
Manacor
Country
Spain
Facility Name
H. General Universitario Santa Lucía
City
Murcia
ZIP/Postal Code
30202
Country
Spain
Facility Name
H. R. U. de Málaga / Materno Infantil
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
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