Effects of a natural ingredient-based vaginal gel on vaginal health
| ISRCTN | ISRCTN77955077 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77955077 |
| Secondary identifying numbers | Paloma15/1 |
- Submission date
- 01/02/2017
- Registration date
- 15/02/2017
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Cervical ectopy is a benign (harmless) condition that causes the delicate cells that line the cervix (birth canal) to be found on the surface outside of the cervix. This can be caused by childbirth, sexual intercourse and birth control use. For the majority of women this does not cause any problems but it can lead to higher amounts of vaginal discharge (mucous) and to bleeding after sexual intercourse. In order for this condition to be treated, a colposcopy (a procedure where the inside of the cervix is examined using a special microscope with a light (a colposcope)) is used to freeze or cauterise (burn) the cells. However, the ectopic tissue can reoccur therefore alternative treatment can be helpful. Palomacare® is a gel which acts as a moisturiser and can help repair cells. This study evaluates if Palomacare® gel can help to treat cervical ectopy and improve vaginal health in women.
Who can participate?
Women aged 18-45.
What does the study involve?
Participants attend a routine gynaecological visit (where they have a vaginal examination and colposcopy) and are then instructed on how to correctly use a vaginal gel called Palomacare® every day at bedtime for 12 days. Participants are followed up with a vaginal examination and colposcopy after 12 days to evaluate vaginal health.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their vaginal health. There are no notable risks to participants.
Where is the study run from?
Instituto Palacios de Salud y Medicina de la Mujer (Spain)
When is the study starting and how long is it expected to run for?
December 2014 to April 2015
Who is funding the study?
Procare Health (Spain)
Who is the main contact?
Dr Santiago Palacios
Contact information
Public
Passeig del Ferrocarril 339
Castelldefels
08060
Spain
Scientific
Instituto Palacios de Salud y Medicina de la Mujer
Antonio Acuña 9
Madrid
E-28009
Spain
 ORCID ID |
0000-0003-2229-1200 |
|---|
Study information
| Study design | Observational open-label single cohort prospective pilot clinical study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN77955077_PIS_07Feb17_Spanish.docx |
| Scientific title | Beneficial effects of a Coriolus versicolor-based vaginal gel on cervical epithelization, vaginal microbiota and vaginal health: A pilot study in asymptomatic women |
| Study objectives | The aim of this study is to assess the clinical benefits of Coriolus versicolor-based vaginal gel (Palomacare®) on epithelization of cervical lesions and to improve vaginal microbiota and vaginal health in asymptomatic healthy women. |
| Ethics approval(s) | This study does not require ethical approval. According to Spanish regulations ethics approval is not required for studies with the following characteristics: real life, pilot study, with a medical device (not a drug) class I already marketed and used within approved indication, and sponsored by the principal investigator and not by a private pharmaceutical company. |
| Health condition(s) or problem(s) studied | Asymptomatic women with ectopia and alterations of the vaginal microbiota |
| Intervention | Participants attend a routine gyneacological visit where they have a vaginal examination and a colposcopy to evaluate their symptoms. They are instructed on how to correctly use the vaginal gel Palomacare® once day at bedtime for 12 days. Palomacare® is a non-hormonal (hyaluronic acid, ß-glucan, alpha-glucan oligosaccharide, Coriolus versicolor, Asian centella, Azadirachta indica and Aloe vera) gel that acts a moisturiser and lubricant because of strong hydrating properties, also enhancing and accelerating repair of atrophic or injured cervicovaginal mucosa. Participants are followed up 12 days after the treatment at the gyneacological with a vaginal examination and a colposcopy to assess their vaginal health and microbiota. |
| Intervention type | Supplement |
| Primary outcome measure | Degree of epithelization of the cervical mucosa is evaluated by standard colposcopy and rated by the the investigator using the ectopy ephithelization score at baseline and 12 days. |
| Secondary outcome measures | 1. Vaginal microbiota is evaluated using the Vagina Status-Diagnostic test (Instiüt für Mikroökologie, Herborn, Germany) and further rated by the investigator using a 5-point Liker scale at baseline and 12 days 2. The vaginal health is assessed by the Bachmman Vaginal Health Index at baseline and 12 days |
| Overall study start date | 01/12/2014 |
| Completion date | 01/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 21 |
| Total final enrolment | 21 |
| Key inclusion criteria | 1. Women aged between 18 and 45 years old 2. No signs and symptoms of vaginal disease 3. Normal Papanicolaou smear |
| Key exclusion criteria | 1. Vaginal infections 2. Use of vaginal products other than the investigational compound 3. Being pregnant or breastfeeding. 4. History or concomitant diseases who are deemed to be ineligible by the investigator |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 01/03/2015 |
Locations
Countries of recruitment
- Spain
Study participating centres
Madrid
28009
Spain
Barcelona
08022
Spain
Sponsor information
Hospital/treatment centre
Antonio Acuña 9
Madrid
E-28009
Spain
"ROR" |
https://ror.org/01kvepn75 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study is not expected to be made available due to confidentiality reasons. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 07/02/2017 | 21/02/2017 | No | Yes | |
| Results article | 16/03/2017 | 29/01/2019 | Yes | No |
Additional files
- ISRCTN77955077_PIS_07Feb17_Spanish.docx
- Uploaded 21/02/2017
Editorial Notes
14/11/2022: Total final enrolment added.
29/01/2019: Publication reference added
21/02/2017: Uploaded participant information sheet.
