Condition category
Urological and Genital Diseases
Date applied
01/02/2017
Date assigned
15/02/2017
Last edited
21/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Josep Combalia

ORCID ID

Contact details

Passeig del Ferrocarril 339
Castelldefels
08060
Spain

Type

Scientific

Additional contact

Dr Santiago Palacios

ORCID ID

http://orcid.org/0000-0003-2229-1200

Contact details

Instituto Palacios de Salud y Medicina de la Mujer
Antonio Acuña 9
Madrid
E-28009
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Paloma15/1

Study information

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

Acronym

Study hypothesis

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

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.

Study design

Observational open-label single cohort prospective pilot clinical study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (Spanish)

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2014

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged between 18 and 45 years old
2. No signs and symptoms of vaginal disease
3. Normal Papanicolaou smear

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

21

Participant 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

Recruitment start date

01/02/2015

Recruitment end date

01/03/2015

Locations

Countries of recruitment

Spain

Trial participating centre

Instituto Palacios de Salud y Medicina de la Mujer
C/ Antonio Acuña 9
Madrid
28009
Spain

Trial participating centre

Clínica Sagrada Família
Torras i Pujalt, 1
Barcelona
08022
Spain

Sponsor information

Organisation

Instituto Palacios de Salud y Medicina de la Mujer

Sponsor details

Antonio Acuña 9
Madrid
E-28009
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Procare Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/09/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/02/2017: Uploaded participant information sheet.