Papilocare FAQ

There are four main factors that relate to the persistence of HPV and its ability to colonize the cells of the cervix.

1. The viral genotype

2. The histological structure of the cervix

3. The status of the vaginal microbiota

4. The woman’s immune status

The cervix has a very unstable histological structure, with the permanent confrontation of two epithelia, the vaginal polystratified squamous epithelium and endocervical columnar glandular epithelium. Underneath this glandular epithelium lies so-called reserve cells. These retain the ability to grow and differentiate more often into mature forms of squamous epithelium or glandular epithelium. This process has been called metaplasia and creates a more or less extensive area identified as the transformation zone in the cervix. Cervical re-epithelialization is a normal process in sexually active women, increased in users of hormonal contraceptives, IUDs or who have had children.

To integrate itself, HPV needs cells undergoing mitotic activity. The reserve cells involved in the metaplasia process fulfill this condition and therefore are ideal targets for anchoring HPV. Consequently, a well-epithelialized cervix with squamous epithelium, and a limited or nonexistent transformation zone would not provide a suitable environment for cellular colonization – and therefore for the oncogenic potential of HPV.

The microbiota plays an important role in human health. Specifically, the vaginal microbiota is made up of a large variety of lactobacilli, whose balance and diversity can have an effect on local immune status and vice versa. Recent data clearly demonstrate that this balance determines the pathogenesis of HPV in cervical cancer. The more the microbiota is altered (greater diversity of microorganisms and a lower concentration of lactobacilli), the greater the probability of HPV persistence and severity of the lesions it causes.

A woman’s local immune status is one of the three modifiable circumstances that may be related to the clearance or persistence of HPV. It is known that immunocompromised patients have a high risk of developing HPV-dependent lesions.

Epithelial cells provide a first line of defense that confers continuous protection, by providing a physical barrier against pathogenic microorganisms, allergens or toxic environmental particles. When the integrity of mucosal epithelium is compromised it can lead to the development of several diseases.

Also, recent data have shown a significant correlation between the local immune status of women and the persistence of high-risk HPV genotypes.

Moreover, HPV creates an anti-inflammatory local microenvironment, making difficult to be detected by the local immune system and thus preventing an adequate immune response.

The re-establishment of the natural conditions needed to counteract the non-inflammatory environment (created by the HPV) and restore the microbiota has the potential to improve viral clearance.

Mucosal barriers, such as the cervico-vaginal mucosa, are the body’s first line of defense against external pathogens. They are formed by epithelial cells and the substances they secrete. In a healthy microenvironment, tight junctions between the paracellular space and the presence of mucus on epithelium surface, prevents the passage of external microorganisms (such as virus and bacteria) and toxins into the tissue. The reduction in this defensive barrier function can lead to disease and can also hinder the natural healing process.

Papilocare vaginal gel creates a film that prevents abrasions, micro lesions and lesions on cervical-mucosa and protects damaged epithelium from external agents’ exposure. This muco-adhesive gel, specifically formulated for this purpose, combines selected ingredients which act synergistically on three modifiable factors related to the clearance or persistence of HPV-induced low grade cervical lesions:

1. The histological structure of the ectocervix

2. The status of the vaginal microbiota balance

3. The woman’s immune status

Papilocare vaginal gel’s muco-protective, re-epithelizing and microbiota balancing actions restore and optimise the defensive barrier role of the cervico-vaginal mucosa, preventing cervical lesions in HPV infected patients and helping to repair HPV-dependent cervical lesions, reestablishing the optimal conditions for a natural healing process.

No. Papilocare is a Class IIa Medical device and does not work in any pharmacological, immunological or metabolic means.

Epithelial cells provide a first line of defense that confers continuous protection, by providing a physical barrier against pathogenic microorganisms, allergens or toxic environmental particles. When the integrity of mucosal epithelium is compromised it can lead to the development of several diseases.

The film created by the mucoadhesive gel together with the re-epithelization action restores the defensive barrier of the cervicovaginal mucosa, avoiding the HPV integration in the lower layers of the stratified epithelium, restoring the conditions needed for a natural healing process.

Moreover, Papilocare has demonstrated its restorative effect on the vaginal microbiota, increasing the Lactobacillus crispatus concentration, which is known to have a positive effect on enhancing the local immune response of the epithelial cells and reducing the Gardnerella Vaginalis.

The preservatives are Sodium Benzoate and Potassium Sorbate.

Niosomes are a novel substance delivery system, in which substances are encapsulated, in a lamellar-structured vesicle composed by a bilayer of non-ionic surfactants and cholesterol, allowing for a higher penetration potential and more prolonged bioavailability than other emulsions used previously.

As with niosomes, phytosomes are an innovative substance delivery system, with the difference that they are developed for the delivery of plant extracts with therapeutic effects.

The ingredients with a niosomal formulation are hyaluronic acid, kaempferol and β-glucan. The ingredient with a phytosomal formulation is Centella asiatica. The innovative technologies improve bioavailability of these ingredients on cervical mucosa by deeper penetration at the basal level and prolonged release for an overall more durable effect of Papilocare.

Papilocare does not contain Thiomersal or derivatives. As preservatives, it contains Potassium Sorbate and Sodium Benzoate. Furthermore, it does not contain parabens or fragrances.

Papilocare is indicated for HPV+ patients without lesions or for HPV+ patients with ASCUS or LSIL. Papilocare® is the 1st clinically proven treatment to prevent and treat HPV-dependent cervical lesions. HPV-infected patients do not necessarily have lesions. In fact, many patients do not have lesions and will benefit fully from the preventive action of Papilocare. In addition, for patients already presenting lesions, Papilocare improves lesion repair, rebalancing the vaginal microbiota and restoring the optimal conditions for the natural local immunity response, therefore avoiding the development of new lesions caused by the same or another type of HPV.

The recommended treatment duration is six months, as described below:

FIRST MONTH:

Apply one cannula daily for 21 consecutive days. (Start treatment after your period / take a break of 7 days after first 21 days of treatment)

MONTH 2 TO 6 (5 following months):

Apply one cannula every other day (11 cannulas per month) until the 6 months of treatment is completed (except during the menstrual period, if it exists).

Yes. It is possible and normal for some gel to remain inside the cannula. This does not mean that a lower dose than recommended has been administered as the cannula releases a sufficient amount for covering the cervical mucosa.

Normally, the gel does not leak excessively, although some discharge of the product can be normal. Even though some patients may have a dripping sensation, it is very likely that the necessary and sufficient amount of Papilocare has reached its target thanks to the very good absorption of the product due to the niosomal technology.

In addition, the risk of dripping is less likely if the product is properly applied. Remember to apply the product before going to bed, inserting the cannula into the vagina and squeezing from bottom to the top of the cannula until its contents are emptied. Next, remove the cannula from the vagina while continuing to squeeze it in order to avoid sucking out the product that has just been administered.

No, Papilocare does not replace vaccination. Vaccination is used for primary prevention, which is not an indication for Papilocare. Papilocare is indicated for HPV+ patients without lesions or for HPV+ patients with ASCUS or LSIL. Papilocare is the first clinically proven treatment to prevent and treat HPV-dependent cervical lesions. Papilocare is recommended for both vaccinated and unvaccinated women.

HPV infection and HPV-induced lesions are generally asymptomatic. A patient may be diagnosed as HPV+ following her routine HPV Screening appointment. For its treatment indication, Papilocare may be recommended when there is a HPV positive test result and/or when ASCUS/LSIL HPV-induced lesions are detected by cytology and colposcopy. For its HPV-induced low grade cervical lesions prevention indication, Papilocare use might start as soon as a positive HPV test result.

Yes, you can have sexual relations while using Papilocare. In fact, Papilocare is compatible with the use of condoms. Nevertheless, it is recommended to apply Papilocare after intercourse and correct hygiene, just before going to bed.

Yes, a compatibility study of Papilocare with latex condoms has been done. The study evaluated changes in condoms properties according to AFNOR – NF S97-034. This procedure was carried out under NF EN ISO 4074:2002. According to the results, it was concluded that Papilocare is compatible with natural latex rubber condoms.

Papilocare is a class lla medical device with a CE mark granted by the Notified Body IMQ s.p.a number 0051. This CE certificate is valid in the European Economic Area (EEA), European Free Trade Association (EFTA) and Turkey.

There is no clinical data available regarding women who are pregnant or breastfeeding.

Papilocare is indicated for the treatment of low-grade lesions (ASCUS, LSIL) caused by HPV in the cervical mucosa. No clinical data is available on high-grade lesions (HSIL).

We have no data with Papilocare in patients using vaginal contraceptives. Therefore, as a precaution, it is better not to use Papilocare in patients wearing a vaginal contraceptive.

Based on the experience accumulated up to present, Papilocare is a very safe and well tolerated product. The only adverse reaction reported after the product was put on the market was irritation, tingling, burning, or itching after application. This reaction is more frequent in women with a very sensitive or somewhat damaged genital area (e.g. vaginal microlesions after intercourse) or in patients with a vaginal pH altered by various causes (e.g. postmenopause or current or recent vaginal infections). This may also be due to an allergy to certain ingredients.

See your doctor to individually assess the evolution of the symptoms because, over time and as the product is administered, it may disappear, decrease/remain yet be tolerable, or not be tolerable, in which case treatment should be discontinued. Suggestion for handling symptoms: stop using the product for two or three days and observe the symptoms. Then, resume the treatment. If the symptoms recur and are not tolerated by the patient, definitively discontinue treatment.

There is no data available on possible interactions of Papilocare with seminal fluid. It is recommended to apply Papilocare, after intercourse and correct intimate hygiene, just before going to bed.

Papilocare is a very safe and generally well tolerated product. The only adverse reaction reported after the product was put on the market was irritation, tingling, or itching after application. You can resume Papilocare treatment once the fungal infection has been cured.

Considering Papilocare’s mechanism of action and characteristics, bleeding is not an adverse effect expected with the use of the product. However, an allergy to certain Papilocare ingredients or incorrect application of the product in the vagina could, in theory, produce some type of inflammation or injury that could cause spotting. In any case, although it is difficult to imagine Papilocare being the cause, discontinue administration of the product and seek a medical examination if this problem arises.

Papilocare is administered and acts intravaginally. Therefore, it does not interfere with the urinary tract and it does not cause an increased urge to urinate at night, nor does urination affect the product’s efficacy.

The only contraindication is that it should not be used by individuals with known hypersensitivity (allergies) to any of its ingredients.