- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210336
Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV (PAPILOCAN)
Estudio clínico, Aleatorizado, Doble Ciego, Paralelo, Controlado Con Placebo Para Evaluar la Eficacia Del Gel Papilocare® en la reparación de Lesiones Cervicales Causadas Por VPH. Randomized, Double-blind, Parallel, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Papilocare® Gel in the Repairment of Cervical Lesions Caused by HPV.
Clinical Trial phase III, randomized, double-blind, placebo-controlled and parallel-group clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or placebo, using a randomization list and in double-blind conditions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Phase III, randomized, double-blind, placebo-controlled and parallel-group clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or placebo, using a randomization list and in double-blind conditions.
The study is divided into 2 parts, the first 100 randomized patients will receive treatment with an administration regimen in both arms: 1 cannula / day for 1 month + 1 cannula on alternate days for 5 months (except for menstruation days). The second part of the study, randomized patients from position 101 to 200, will receive treatment with an administration regimen in both arms: 1 cannula / day for 3 months + 1 cannula on alternate days for 3 months (except the days of menstruation).
Duration of treatment: 6 months Total study duration: 13 months in 5 visits: selection visit, V0 or randomization visit (30 days), V1(Month 3), V2 (Month 6), V3 (Month 12).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tenerife
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Santa Cruz de Tenerife, Tenerife, Spain, 38010
- Hospital Universitario Nuestra Senora de la Candelaria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Woman between the ages of 30 and 65 (both included).
- Able to read and understand the Patient Information Sheet and informed consent
- Accept participation in the study and sign the Informed Consent.
- Cytological result of ASC-US or LSIL, with concordant colposcopic image, at most 3 months before the selection visit. It is considered concordant with ASCUS and LSIL, a colposcopic result of normality, of non-specific findings or of type 1 changes.
- Positive HPV according to cobas 4800 technique (high-risk HPV) carried out in a selection visit (or positive available at most 3 months prior to the baseline visit).
- Women vaccinated and not vaccinated against HPV.
- Is able, at the discretion of the researcher, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout it.
Exclusion Criteria:
- Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
- Other cytological results other than those provided for in the inclusion criteria.
- Baseline LSIL biopsies with CIN-3.
- Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit)
- 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 inclusion of the study.
- Any planned surgery that precludes correct compliance with the guideline.
- Use of vaginal contraceptives or other vaginal hormonal treatments.
- Contraindications to 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 suspected pregnancy or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PAPILOCARE
Randomized patients will receive two different guidelines depending on the time of randomization:
|
Papilocare®: Vaginal Gel based on Coriolus versicolor, medical device class IIa. Route of administration: topical (vaginal). Papilocare® consists of the following ingredients: hyaluronic acid niosomes, β-glucans (magnolol, honokiol and carboxymethyl betaglucan) niosomes, BioEcolia® (Alpha-oligoglycan), Coriolus versicolor, Azadirachta indica (Neem) extract, Centella asiatica and Aloe vera. |
Placebo Comparator: PLACEBO
Randomized patients will receive two different guidelines depending on the time of randomization:
|
The placebo consists of a carrier gel with the absence of the active ingredients of Papilocare®.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cervical mucosal repair
Time Frame: 6 months
|
Percentage of patients with cervical lesions negativization confirmed be cytology and accordance colposcopy , at 6 months will be used to evaluate the main variables, degree of cervical mucosal repair in HPV-positive women with ASC-US or LSIL.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reepithelialization degree of the cervical mucosa
Time Frame: at 3 months
|
Percentage of patients with negativity of cervical lesions by cytology and accordance colposcopy, at 3 months
|
at 3 months
|
Percentage of patients with Viral clearance
Time Frame: 3 and 6 months.
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Percentage of patients with initial HPV clearance measured by PCR at 3 and 6 months.
|
3 and 6 months.
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Vaginal health status measured by vaginal health index (VHI)
Time Frame: 3 and 6 months.
|
Changes in the VHI (vaginal health index -Bachmann) at 3 and 6 months. VHI was developed in order to objectively assess female urogenital health (Bachmann GMaturitas. 1995 Dec; 22 Suppl():S1-S5.). This test evaluates overall elasticity, fluid secretion type and consistency, vaginal pH, epithelial mucosa and moisture. Minimum score is 5 and maximum is 25. Lower scores corresponds to greater urogenital atrophy. |
3 and 6 months.
|
Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
Time Frame: 3 and 6 months.
|
Changes PSS-14 scale (Perceived Stress Scale 14 items) at 3 and 6 months. The PSS-14 is comprised of 14 items, score ranges from 0-56, with higher scores indicating greater perceived stress |
3 and 6 months.
|
Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
Time Frame: 6 months
|
Record of the incidence, nature and severity of adverse events: during the 6 months of treatment duration.
|
6 months
|
Satisfaction degree with Papilocare gel use: Likert type scale
Time Frame: 3 and 6 months.
|
Patients satisfaction degree with papilocare gel use as treatment will be evaluated by a likert type scale. A Likert scale is a psychometric scale commonly involved in research that employs questionnaires. It is the most widely used approach to scaling responses in survey research.Likert scaling assumes distances between each choice (answer option) are equal. Higher scores corresponds to better satisfaction with papilocare gel use. |
3 and 6 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of biopsy results (optional)
Time Frame: 3 and 6 months.
|
Only in cases that a biopsy has been performed per routine, the change or maintenance of biopsy results will be evaluated.
|
3 and 6 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alfonso Quesada López-Fe, Doctor, H Nuestra Señora de la Candelaria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAPILOCAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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