Human papillomavirus infection Infections and Infestations
Conditions
Interventions
Women who gave consent to participate in the study and met the inclusion criteria were advised on the appropriate use of the vagina gel product Papilocare®. Participants were visited at baseline (scre
Sponsors
Gabinete Médico Velázquez SL
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Sexually active women 2. 25 years of age and older 3. Attending a routine control gynecologic visit 4. Normal Papanicolaou smear and normal colposcopic findings 5. Diagnosis of HPV positivity by polymerase chain reaction (PCR)-based HPV DNA detection within 3 months before consultation.
Exclusion criteria
Exclusion criteria: 1. Clinically relevant disorders of the immune system 2. Treatment with immunosuppressant agents 3. Abnormal vaginal bleeding (without diagnosis) within the 6 months prior to the screening visit 4. Symptomatic vulvovaginal infection 5. History of gynecologic cancer 6. Use of vaginal contraceptives or other vaginal hormonal treatments 7. Planned surgery preventing compliance with treatment 8. Current participation in a current clinical trials or in the previous 4 weeks 9. Fertile women not using effective contraceptive methods 10. Pregnant or breastfeeding 11. Contraindication for the use of Papilocare® or known allergies to some of its components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The epithelization degree of the cervical mucosa was assessed by the investigator by standard colposcopy and rated using a 5-point Likert scale, where 5 was no ectopy, 4: mild (50% of the external os) and 1: severe ectopy and bleeding. This variable was measured at baseline and 21 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| The composition of bacterial communities was assessed by calculating three major ecological parameters, including the Chao1 richness index for abundance data (an estimate of a total community), the Pielou’s evenness index (to show how evenly the individuals in the community were distributed over different operational taxonomic units [OUT]) , and the Shannon biodiversity index (a combined parameter of richness and evenness) [34]. The Shannon biodiversity index was categorized as 3 (high diversity). This variable was measured at baseline and 21 days. | — |
Countries
Spain
Outcome results
None listed