An interventional study of PAPILOCARE and LACTIC ACID GEL in HPV Infection and Lesion Cervix, sponsored by Procare Health Iberia S.L.. Completed at 1 site in Spain. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Procare Health Iberia S.L. · Not applicable, Interventional, and Treatment
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.
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).
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 200 is close to the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Procare Health Iberia S.L. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) .
Device: PAPILOCARE
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) .
Device: LACTIC ACID GEL
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.
The lactic acid gel consists of a carrier gel with the absence of the active ingredients of Papilocare®.
cervical mucosal repair
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.
Time frame: 6 months
Reepithelialization degree of the cervical mucosa
Percentage of patients with negativity of cervical lesions by cytology and accordance colposcopy, at 3 months
Time frame: at 3 months
Percentage of patients with Viral clearance
Percentage of patients with initial HPV clearance measured by PCR at 3 and 6 months.
Time frame: 3 and 6 months.
Vaginal health status measured by vaginal health index (VHI)
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.
Time frame: 3 and 6 months.
Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
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
Time frame: 3 and 6 months.
Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
Record of the incidence, nature and severity of adverse events: during the 6 months of treatment duration.
Time frame: 6 months
Satisfaction degree with Papilocare gel use: Likert type scale
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.
Time frame: 3 and 6 months.
Change of biopsy results (optional)
Only in cases that a biopsy has been performed per routine, the change or maintenance of biopsy results will be evaluated.
Time frame: 3 and 6 months.
Plan to share: Yes — The PI from the participant site received the study protocol and the informed consent form previously to the initiation of the study and every time it occurs an amendment over the protocol, ICF or any other study document. Once the study will finish and the data will be analyzed, the PI will receive the CSR.
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Procare Health Iberia S.L.