Vaginal DysbiosisDISPALOMANCT06668012
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
A study testing Palomacare® vaginal gel is a medical device with CE class IIa. in people with Vaginal Dysbiosis, run by Procare Health Iberia S.L. at 2 sites in Spain.
Trial summary
The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in order to try to prevent the appearance of future established vaginal infections. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vaginal Dysbiosis
- What is being tested?
- Palomacare® vaginal gel is a medical device with CE class IIa.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 12 Dec 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 45 years of age, inclusive.
- Who are attending a gynecological visit for any reason and who are in the first phase of the menstrual cycle, between the end of menstruation and before ovulation (approximately between days 9 and 15).
- With regular menstrual cycles of between 24 and 35 days.
- Who are able to understand and sign the informed consent after the nature of the study has been fully explained to them.
- With a vaginal pH higher than 4.5 with or without symptoms
Who cannot join
- Diagnosis of another vaginal or vulvar condition that may confuse the interpretation of the response to the investigational product (erosive lichen planus, inflammatory desquamative vaginitis, or contact dermatitis involving the vulvar epithelium).
- Diagnosis of cervical intraepithelial neoplasia (CIN), cervical carcinoma, or endometrial neoplasia.
- Active genitourinary infections (VVC, N. gonorrhoeae, C. trachomatis, or T. vaginalis) at the time of inclusion or within 15 days prior to inclusion in the study.
- Active genital lesions (ulcers or vesicles compatible with herpes or warts) or genital bleeding.
- Pregnant patients or in the immediate postpartum period (up to 40 days).
- Contraception with copper IUD.
Show all 12Show fewer
- Use of oral or topical antibiotics, or vaginal antifungals in the two weeks prior to the initial visit.
- Planned immunosuppressive therapy.
- Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.).
- Use of any other experimental drug or device during the 30 days prior to selection.
- Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatments.
- Inability, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems or due to psychophysical characteristics.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Clínica Sagrada Familia
Barcelona, 08022
Fernando Losa, Doctor, +34 932 12 23 00, losa.fernando@gmail.com
- Recruiting
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, 41720
Santiago Palacios, MD
About this study
Official title: A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in order to try to prevent the appearance of future established vaginal infections.
Read the detailed description
Multicenter, open, comparative study, where all eligible patients with vaginal dysbiosis (vaginal pH >4.5) will be assigned to one of the 3 study groups (1:1:1) according to the randomization list for random assignment to groups B and C:
- Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up
2 visits will be made throughout the study: visit 1 (initial visit, between days 9 and 15 of the menstrual cycle) and visit 2 (final visit, within 5 days after the end of treatment or equivalent in the case of the monitored follow-up group, always before the next menstruation).
The study will consist of two phases; the first phase or PILOT, where 30 patients (10 per group) will be included with the intervention of 2 centers, and a second phase or EXTENSION, where 60 additional patients (20 per group) will be included, obtaining a total of 90 patients (30 per group) at the end of the study.
- Conditions
- Vaginal Dysbiosis
- Being tested
- Palomacare® vaginal gel is a medical device with CE class IIa.
- Keywords
- Vaginal, Palomacare, Dysbiosis
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palomacare® vaginal gel is a medical device with CE class IIa.Device
The duration of the study for each patient will be approximately 11-12 days and the treatment for groups A and B will be 6 days.
In a first pilot study in asymptomatic women, a tendency towards a positive effect on the composition of vaginal fluid was already observed, as assessed by diagnostic tests and classified using a Likert scale. A subsequent study showed that treatment with a different vaginal gel but with an identical concentration of ingredients from Palomacare® vaginal gel, for 21 consecutive days, is able to improve the composition of vaginal fluid.
Based on these preliminary data, it is possible to hypothesize that the action of Palomacare® vaginal gel will have a positive effect on the composition of vaginal fluid in patients affected by dysbiosis, whether asymptomatic or not.
| Study group | Role | What they receive |
|---|---|---|
| A - Symptomatic patients | Active comparator | Treatment with Palomacare® vaginal gel for 6 days Receives: Device: Palomacare® vaginal gel is a medical device with CE class IIa. |
| B - Asymptomatic patients | Active comparator | Treatment with Palomacare® vaginal gel for 6 days Receives: Device: Palomacare® vaginal gel is a medical device with CE class IIa. |
| C - Asymptomatic patients | No intervention | Monitored follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Palomacare® vaginal gel on vaginal microbiota (VM)
To evaluate the effect of Palomacare® vaginal gel on VM, the change in microbial diversity, vaginotype and taxonomic profile of the vaginal microbiome will be analyzed between V1 and V2 in each group.
Measured: Through study completion, an average of 12 days
Secondary outcomes (3)
Effect of Palomacare® vaginal gel on symptoms and pH
To assess the effect of Palomacare® vaginal gel on:
- Symptoms (amine odour, leucorrhoea and itching): for each symptom an VAS intensity scale will be used and the time to show changes in each of the symptoms will be assessed by directly asking the patient.
- Vaginal pH: vaginal pH refers to the degree of acidity of the vaginal environment. Adequate vaginal pH levels should be between 3.8 - 4.4. However, these vary throughout the woman's cycle and at different stages of life. The researcher will carry out this measurement at visit 1 and visit 2, noting the numerical value of the patient's vaginal pH.
Measured: Through study completion, an average of 12 days
Satisfaction with the use of Palomacare® vaginal gel
To assess the degree of satisfaction regarding the use of Palomacare® vaginal gel using a 5-point Likert scale at visit 2.
Measured: Through study completion, an average of 12 days
Safety and tolerability of Palomacare® vaginal gel
To assess the safety and tolerability of Palomacare® vaginal gel using a 5-point Likert-type scale at visit 2 and by describing the incidence, nature and severity of adverse events (AEs) throughout the study.
Measured: Through study completion, an average of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start12 Dec 2024
- Primary completion20 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, open, comparative study, where all eligible patients with vaginal dysbiosis (vaginal pH \>4.5) will be assigned to one of the 3 study groups (1:1:1) according to the randomization list for random assignment to groups B and C: A. Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Santiago Palacios Gil-Antuñano, MD, Principal investigator, Instituto Palacios de Salud y Medicina de la MujerDr. Fernando Losa Domínguez, MD, Principal investigator, Clínica Sagrada Familia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668012
- Sponsor's protocol ID
- DISPALOMA
- Acronym
- DISPALOMA
- Status last verified
- Jan 2025
- First submitted
- 29 Oct 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be discussed
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
- ClinicalTrials.gov ID
- NCT06668012
- Acronym / sponsor ID
- DISPALOMA / DISPALOMA
- Conditions
- Vaginal Dysbiosis
- Keywords
- Vaginal, Palomacare, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in order to try to prevent the appearance of future established vaginal infections.
Detailed description
Multicenter, open, comparative study, where all eligible patients with vaginal dysbiosis (vaginal pH >4.5) will be assigned to one of the 3 study groups (1:1:1) according to the randomization list for random assignment to groups B and C:
- Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up
2 visits will be made throughout the study: visit 1 (initial visit, between days 9 and 15 of the menstrual cycle) and visit 2 (final visit, within 5 days after the end of treatment or equivalent in the case of the monitored follow-up group, always before the next menstruation).
The study will consist of two phases; the first phase or PILOT, where 30 patients (10 per group) will be included with the intervention of 2 centers, and a second phase or EXTENSION, where 60 additional patients (20 per group) will be included, obtaining a total of 90 patients (30 per group) at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter, open, comparative study, where all eligible patients with vaginal dysbiosis (vaginal pH >4.5) will be assigned to one of the 3 study groups (1:1:1) according to the randomization list for random assignment to groups B and C: A. Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up
| Arm | Type | Receives |
|---|---|---|
| A - Symptomatic patients | Active comparator | Device: Palomacare® vaginal gel is a medical device with CE class IIa.Treatment with Palomacare® vaginal gel for 6 days |
| B - Asymptomatic patients | Active comparator | Device: Palomacare® vaginal gel is a medical device with CE class IIa.Treatment with Palomacare® vaginal gel for 6 days |
| C - Asymptomatic patients | No intervention | –Monitored follow-up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 18 and 45 years of age, inclusive.
- Who are attending a gynecological visit for any reason and who are in the first phase of the menstrual cycle, between the end of menstruation and before ovulation (approximately between days 9 and 15).
- With regular menstrual cycles of between 24 and 35 days.
- Who are able to understand and sign the informed consent after the nature of the study has been fully explained to them.
- With a vaginal pH higher than 4.5 with or without symptoms
Key exclusion criteria (12 listed)
- Diagnosis of another vaginal or vulvar condition that may confuse the interpretation of the response to the investigational product (erosive lichen planus, inflammatory desquamative vaginitis, or contact dermatitis involving the vulvar epithelium).
- Diagnosis of cervical intraepithelial neoplasia (CIN), cervical carcinoma, or endometrial neoplasia.
- Active genitourinary infections (VVC, N. gonorrhoeae, C. trachomatis, or T. vaginalis) at the time of inclusion or within 15 days prior to inclusion in the study.
- Active genital lesions (ulcers or vesicles compatible with herpes or warts) or genital bleeding.
- Pregnant patients or in the immediate postpartum period (up to 40 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palomacare® vaginal gel is a medical device with CE class IIa.The duration of the study for each patient will be approximately 11-12 days and the treatment for groups A and B will be 6 days. In a first pilot study in asymptomatic women, a tendency towards a positive effect on the composition of vaginal fluid was already observed, as assessed by diagnostic tests and classified using a Likert scale. A subsequent study showed that treatment with a different vaginal gel but with an identical concentration of ingredients from Palomacare® vaginal gel, for 21 consecutive days, is able to improve the composition of vaginal fluid. Based on these preliminary data, it is possible to hypothesize that the action of Palomacare® vaginal gel will have a positive effect on the composition of vaginal fluid in patients affected by dysbiosis, whether asymptomatic or not. | Device | A - Symptomatic patients, B - Asymptomatic patients |
Primary outcome
Effect of Palomacare® vaginal gel on vaginal microbiota (VM)
Time frame: Through study completion, an average of 12 days
To evaluate the effect of Palomacare® vaginal gel on VM, the change in microbial diversity, vaginotype and taxonomic profile of the vaginal microbiome will be analyzed between V1 and V2 in each group.
3 secondary outcomes
Effect of Palomacare® vaginal gel on symptoms and pH
Time frame: Through study completion, an average of 12 days
Satisfaction with the use of Palomacare® vaginal gel
Time frame: Through study completion, an average of 12 days
Safety and tolerability of Palomacare® vaginal gel
Time frame: Through study completion, an average of 12 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No. To be discussed
Related trials for Vaginal Dysbiosis
Recruiting
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
Endometriosis, Microbiome Dysbiosis
RecruitingPhase 2
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
Vaginal Dysbiosis
RecruitingObservational study
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
Pelvic Toxicity, Radiation Toxicity
Not yet recruitingPhase 3
AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth
Bacterial Vaginosis, Vaginal Dysbiosis
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Santiago Palacios Gil-Antuñano, MD principal investigator
Instituto Palacios de Salud y Medicina de la Mujer
Dr. Fernando Losa Domínguez, MD principal investigator
Clínica Sagrada Familia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palomacare® vaginal gel is a medical device with CE class IIa. in people with Vaginal Dysbiosis, run by Procare Health Iberia S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josep Combalia, MD (+34 93 645 54 41, combalia.j@procarehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Palomacare® vaginal gel on vaginal microbiota (VM) (time frame: Through study completion, an average of 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.