Clinical trial NCT04210336: Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Infection
Lesion Cervix
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: Inclusion Criteria:

1. Woman between the ages of 30 and 65 (both included).
2. Able to read and understand the Patient Information Sheet and informed consent
3. Accept participation in the study and sign the Informed Consent.
4. 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.
5. 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).
6. Women vaccinated and not vaccinated against HPV.
7. 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:

1. Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
2. Other cytological results other than those provided for in the inclusion criteria.
3. Baseline LSIL biopsies with CIN-3.
4. Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit)
5. Other symptomatic vulvovaginal infections.
6. Surgical cervical excision in the last year or total hysterectomy.
7. Previous history of gynecological cancer.
8. Participation in any other clinical trial at present or in the 4 weeks prior to inclusion of the study.
9. Any planned surgery that precludes correct compliance with the guideline.
10. Use of vaginal contraceptives or other vaginal hormonal treatments.
11. Contraindications to the use of Papilocare® gel or known allergies to any of its components.
12. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspected pregnancy or breastfeeding.

Primary outcomes:
measure: cervical mucosal repair
timeFrame: 6 months
Secondary outcomes:
measure: Reepithelialization degree of the cervical mucosa
timeFrame: at 3 months
measure: Percentage of patients with Viral clearance
timeFrame: 3 and 6 months.
measure: Vaginal health status measured by vaginal health index (VHI)
timeFrame: 3 and 6 months.
measure: Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
timeFrame: 3 and 6 months.
measure: Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
timeFrame: 6 months
measure: Satisfaction degree with Papilocare gel use: Likert type scale
timeFrame: 3 and 6 months.
Other outcomes:
measure: Change of biopsy results (optional)
timeFrame: 3 and 6 months.
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de la Candelaria
state: Tenerife
Study officials:
affiliation: H Nuestra Señora de la Candelaria
name: Alfonso Quesada López-Fe, Doctor
role: PRINCIPAL_INVESTIGATOR
References: