Procare Health released results from their latest clinical trial, Paloma 2, confirming the efficacy of Papilocare®, a vaginal gel designed to repair low-grade cervical lesions and to clear Human Papillomavirus (HPV)

MADRID, March 25, 2025 /PRNewswire/ -- Key Findings and Scientific Evidence

The Paloma 2 clinical trial, conducted in 19 Spanish hospitals, involved 164 women with an average age of 41.13 years. All participants tested positive for high-risk HPV and presented with low-grade cervical lesions. The trial compared two groups: one received intensive treatment with Papilocare®, while the other followed standard clinical practice (watchful approach).

The results demonstrated that 88% of the women treated with Papilocare® cleared the virus after a 6-month treatment period, compared to 46% in the control group. This difference was statistically significant (p=0.0011), reinforcing earlier findings from the Paloma 1 trial, which reported an 81.8% repaired cervical lesions. Additionally, the therapeutic benefit persisted at the 12 months follow up visit, confirming Papilocare®'s mid-term efficacy in reducing HPV persistence.

Mechanism of Action and Safety

Papilocare® incorporates a unique formulation based on the natural Asian fungus Coriolus versicolor. Its advanced delivery technology utilizes niosomes and phytosomes, ensuring effective absorption and sustained action on cervical tissue. The gel forms a protective barrier over the cervical mucosa, acting as a defensive shield that prevents HPV integration.

The trial also confirmed that Papilocare® is safe and well-tolerated. The treatment regimen included three months of daily application, followed by three additional monthsof alternate-day use. No significant adverse effects were reported during the study.

A Paradigm Shift in HPV Management

For years, low-grade HPV-induced cervical lesions were managed with a watchful approach rather than proactive intervention. According to Dr. Luis Serrano, an expert in cervical pathology at HM Gabinete Velázquez, Madrid "The Paloma 2 results mark a significant turning point by offering an effective noninvasive active therapeutic approach to reduce HPV persistence and prevent cervical lesion progression."

Impact on Public Health

Cervical cancer is a major public health concern, with approximately 3,200 new cases and 850 deaths reported annually in the UK. Current preventive strategies emphasize vaccination, screening, and early treatment of precancerous lesions. While vaccination effectively prevents up to seven high-risk HPV genotypes, Papilocare® offers a complementary therapeutic option for patients who have already contracted the virus.

Approximately 14% of Spanish women aged 18-65 are HPV-positive. While most clear the virus naturally within two years, persistent infection poses the greatest risk of developing cervical lesions that can progress to cancer. Papilocare®'s proven efficacy in accelerating HPV clearance offers a valuable tool in reducing these risks.

Procare Health's Role

Founded in 2012, Procare Health is a Spanish pharmaceutical company specializing in natural, evidence-based solutions for women's health. With over 10 clinical studies involving 1,500 patients, Papilocare® is now available in more than 55 countries worldwide.

The Paloma 2 trial reinforces Papilocare® as a scientifically validated treatment option for reducing HPV persistence and promoting cervical health.

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