Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV (PAPILOCAN)

Procare Health

Status: Completed

Conditions: HPV Infection; Lesion Cervix

Treatments: Device: PAPILOCARE; Device: LACTIC ACID GEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04210336

PAPILOCAN

Details and patient eligibility

About

Clinical Trial phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel 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 lactic acid gel, using a randomization list and in double-blind conditions.

Full description

Phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel 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 lactic acid gel, 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).

Enrollment: 200 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups

PAPILOCARE

Experimental group

Description:

Randomized patients will receive two different guidelines depending on the time of randomization: * Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ). * Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) .

Treatment:

Device: PAPILOCARE

LACTIC ACID GEL

Active Comparator group

Description:

Randomized patients will receive two different guidelines depending on the time of randomization: * Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ). * Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) .

Treatment:

Device: LACTIC ACID GEL