Evaluating the effect of a non-hormonal vaginal gel on the cervix and vagina of HPV-positive women
| ISRCTN | ISRCTN13043765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13043765 |
| Secondary identifying numbers | EPI001 |
- Submission date
- 01/03/2019
- Registration date
- 02/04/2019
- Last edited
- 11/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The aim of the study was to evaluate the effect of the vaginal application of the Papilocare® gel on different aspects related to your vaginal health, among others, on the regeneration of the cervical mucosa and the state of the vaginal flora, of women with presence of human papillomavirus, but no lesion visible on colposcopy.
Who can participate?
Sexually active women, 25 years of age and older, attending a routine control gynecologic visit, infected with human papillomavirus but with normal results in cytology and colposcopy.
What does the study involve?
All participants received the same treatment, Papilocare, a non-hormonal vaginal gel once daily for 21 consecutive days, preferably at bedtime
What are the possible benefits and risks of participating?
Possible benefits: improving both the regeneration of the cervical mucosa and the state of the vaginal flora. These effects improve your vaginal health.
No important risks were expected.
Where is the study run from?
Service of Gynaecology, Policlínico HM Gabinete Velázquez, Madrid, Spain. Vagina flora samples were evaluated in CIBER-EHD, Department of Pharmacology, University of Granada, Spain.
When is the study starting and how long is it expected to run for?
July 2016 to January 2017.
Who is funding the study?
Work time dedicated to this study by University of Granada personnel falls within funds from Regional Government of Andalucía and by the Spanish Ministry of Economy and Competitiveness with funds from the European Union.
Procare Health SL (Castelldefels, Barcelona, Spain), owner of Papilocare provided logistic support for the study but had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
Who is the main contact?
Julio Galvez
jgalvez@ugr.es
Contact information
Scientific
Centre for Biomedical Research, University of Granada, Avenida del Conocimiento s/n
Granada
18016
Spain
 ORCID ID |
0000-0001-9085-8147 |
|---|---|
| Phone | +34-958-241793 |
| merodri@ugr.es |
Study information
| Study design | A non-comparative, open-label, prospective, and pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN13043765_PIS_22Mar19.docx |
| Scientific title | Effect of a Coriolus versicolor-based vaginal gel on cervical epithelization and vaginal microbiota in HPV-positive women with normal cytology and colposcopy: a pilot study |
| Study acronym | Epicervix |
| Study objectives | Evaluating the impact of the non-hormonal vaginal gel Papilocare® on cervical epithelization and the composition of vaginal microbiota in HPV-positive women with normal cytology and colposcopy. |
| Ethics approval(s) | Approval of the study protocol by the institutional review board was not required because according to the Spanish law (Real Decreto 1591/2009, de 16 de octubre, por el que se regulan los productos sanitarios. Ministerio de Sanidad y Política Social «BOE» núm. 268, de 6 de noviembre de 2009 Referencia: BOE-A-2009-17606. TEXTO CONSOLIDADO. Última modificación: 25 de julio de 2013), studies with a medical device class I (not a drug) already marketed and used within approval indications are exempted. |
| Health condition(s) or problem(s) studied | Human papillomavirus infection |
| Intervention | 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 (screening) (visit 1, inclusion in the study) and after 21 days of treatment (visit 2). In both visits, the degree of epithelization was assessed by colposcopy and samples were obtained to determine the composition of the vaginal microbiota. Recruitment period started in July 2016. The total duration of the study was from July 2016 to January 2017. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 (<25% of the external os), 3: moderate (25–50% of the external os), 2: severe (>50% of the external os) and 1: severe ectopy and bleeding. This variable was measured at baseline and 21 days. |
| Secondary outcome measures | 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 < 2 (low diversity), 2-3 (normal), and > 3 (high diversity). This variable was measured at baseline and 21 days. |
| Overall study start date | 01/07/2016 |
| Completion date | 31/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 21 women |
| Total final enrolment | 21 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 10/07/2016 |
| Date of final enrolment | 05/01/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28001
Spain
Sponsor information
Hospital/treatment centre
Jorge Juan Street, 19 - 1 °
Madrid
28001
Spain
| Phone | 915 77 77 73 |
|---|---|
| lsanchezgonzalez@hmhospitales.com | |
| Website | http://www.gabinetemedicovelazquez.com/index.php/en/# |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Economy and Competitiveness, MINECO, MEC
- Location
- Spain
No information available
Results and Publications
| Intention to publish date | 20/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We plan to publish the results in the BMC Women's Health Journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as patient names were included in the dataset. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 22/03/2019 | 02/04/2019 | No | Yes |
Additional files
- ISRCTN13043765_PIS_22Mar19.docx
- Uploaded 02/04/2019
Editorial Notes
11/12/2020: Sponsor contact details updated.
21/08/2019: Internal review.
29/03/2019: Trial's existence confirmed by Procare Health Iberia, S.L.
