Back to resultsClinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV (PALOMA)
Primary Purpose
Human Papilloma Virus Infection, Human Papilloma Virus, Cervix Lesion
Status
Completed
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 Infection focused on measuring HPV
Eligibility Criteria
Inclusion Criteria:
- Woman between the ages of 30 and 65 (both included).
- Able to read and understand the Patient Information Sheet and the Informed Consent form.
- Accept participation in the study and sign the Informed Consent form.
- Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
- Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
- Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations 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 study.
- Any planned surgery that prevents the correct compliance with the protocol.
- Use of vaginal contraceptives or other vaginal hormonal treatments.
- Contraindications for Papilocare gel use 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 General Universitario de Alicante
- Clínica Diatros - TEKNON
- Women´s Health Institute
- Hospital de la Santa Creu i Sant Pau
- Gabinete Médico Velázquez
- Hospital Infanta Leonor
- Hospital Clínico San Carlos
- Instituto Palacios de Salud y Medicina de la Mujer
- Hospital Quirón Málaga
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
A - papilocare alternative days
B - papilocare semiintensive
C - 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: usual clinical practice: no treatment
Outcomes
Primary Outcome Measures
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Evaluate the repairment of the cervico-vaginal mucosa in positive 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
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Evaluate the repairment of the cervico-vaginal mucosa in positive 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.
Reeptielization of the cervico-vaginal mucosa measured by a likert scale.
Evaluate the reeptielization of the cervico-vaginal mucosa months after the start of treatment measured by likert scale, using a total of 5 points (1 is severe ectopy + external bleeding, 2 is severe or extensive ectopy:> 50%, 3 is moderate ectopy: 25-50%, 4 is mild ectopy: <25% and 5 is no ectopy).
Vaginal health status measured by Bachmann Index.
Evaluate vaginal health status from the start of treatment measured by Bachmann Index, it contains 5 domains that evaluate elasticity, type of secretion, pH, epithelial integrity and moisture, scoring each of them from 1 to 5, considering the maximum score as the best vaginal health status.
Satisfaction of papilocare gel use measured by likert scale.
Evaluate the satisfaction of papilocare gel use by the patients after the start of treatment measured by likert scale, it is a single-item instrument that assesses the degree of satisfaction experienced by the patient with a graded response of 7 values ranging from 1 (satisfied) to 7 (not satisfied at all).
Therapeutic compliance
Evaluate the therapeutic compliance from the start of treatment
Full Information
NCT ID
NCT04002154
First Posted
June 21, 2019
Last Updated
February 12, 2021
Sponsor
Procare Health Iberia S.L.
Collaborators
Adknoma Health Research
1. Study Identification
Unique Protocol Identification Number
NCT04002154
Brief Title
Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV
Acronym
PALOMA
Official Title
Ensayo clínico, Aleatorizado, Abierto, de Grupos Paralelos y Con Grupo Control, Para Explorar la Eficacia Del Gel PAPILOCARE en la reparación de la Mucosa cérvico-vaginal Con Lesiones Causadas Por VPH (Ensayo Clínico PALOMA)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2015 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)
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. All the patients included in the study will be Randomized (1:1:1).
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. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus Infection, Human Papilloma Virus, 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
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A - papilocare alternative days
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
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 - standard of care
Arm Type
No Intervention
Arm Description
Arm C: usual clinical practice: no treatment
Intervention Type
Device
Intervention Name(s)
Papilocare vaginal gel
Intervention Description
Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
Primary Outcome Measure Information:
Title
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Description
Evaluate the repairment of the cervico-vaginal mucosa in positive 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
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Description
Evaluate the repairment of the cervico-vaginal mucosa in positive 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
Reeptielization of the cervico-vaginal mucosa measured by a likert scale.
Description
Evaluate the reeptielization of the cervico-vaginal mucosa months after the start of treatment measured by likert scale, using a total of 5 points (1 is severe ectopy + external bleeding, 2 is severe or extensive ectopy:> 50%, 3 is moderate ectopy: 25-50%, 4 is mild ectopy: <25% and 5 is no ectopy).
Time Frame
3,6 and 12 months
Title
Vaginal health status measured by Bachmann Index.
Description
Evaluate vaginal health status from the start of treatment measured by Bachmann Index, it contains 5 domains that evaluate elasticity, type of secretion, pH, epithelial integrity and moisture, scoring each of them from 1 to 5, considering the maximum score as the best vaginal health status.
Time Frame
3,6 and 12 months
Title
Satisfaction of papilocare gel use measured by likert scale.
Description
Evaluate the satisfaction of papilocare gel use by the patients after the start of treatment measured by likert scale, it is a single-item instrument that assesses the degree of satisfaction experienced by the patient with a graded response of 7 values ranging from 1 (satisfied) to 7 (not satisfied at all).
Time Frame
3 and 6 months
Title
Therapeutic compliance
Description
Evaluate the therapeutic compliance from 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 included).
Able to read and understand the Patient Information Sheet and the Informed Consent form.
Accept participation in the study and sign the Informed Consent form.
Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations 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 study.
Any planned surgery that prevents the correct compliance with the protocol.
Use of vaginal contraceptives or other vaginal hormonal treatments.
Contraindications for Papilocare gel use 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 Cortés Bordoy, MD
Organizational Affiliation
Hospital os Palma de Mallorca
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Clínica Diatros - TEKNON
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Women´s Health Institute
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Gabinete Médico Velázquez
City
Madrid
ZIP/Postal Code
28001
Country
Spain
Facility Name
Hospital Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituto Palacios de Salud y Medicina de la Mujer
City
Madrid
ZIP/Postal Code
41720
Country
Spain
Facility Name
Hospital Quirón Málaga
City
Málaga
ZIP/Postal Code
29004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
It must be discussed with investigators team
Citations:
PubMed Identifier
33743523
Citation
2021 ASCCP Poster Presentations. J Low Genit Tract Dis. 2021 Apr 1;25(2S):9-11. doi: 10.1097/LGT.0000000000000602. No abstract available.
Results Reference
derived
Learn more about this trial
Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV
We'll reach out to this number within 24 hrs