A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)

NCT06668012 | Recruiting

• 1 other identifier: DISPALOMA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Vaginal Dysbiosis

Keywords

Vaginal; Palomacare; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 12 days

Secondary Outcomes (3)

• Effect of Palomacare® vaginal gel on symptoms and pH

  Through study completion, an average of 12 days

• Satisfaction with the use of Palomacare® vaginal gel

  Through study completion, an average of 12 days

• Safety and tolerability of Palomacare® vaginal gel

  Through study completion, an average of 12 days

Study Arms (3)

A - Symptomatic patients

ACTIVE COMPARATOR

Treatment with Palomacare® vaginal gel for 6 days

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

Device: Palomacare® vaginal gel is a medical device with CE class IIa.

C - Asymptomatic patients

NO INTERVENTION

Monitored follow-up

Interventions

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.

A - Symptomatic patients; B - Asymptomatic patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead

Study Sites (2)

Clínica Sagrada Familia

Barcelona, 08022, Spain

RECRUITING

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, 41720, Spain

RECRUITING

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Santiago Palacios Gil-Antuñano, MD

  Instituto Palacios de Salud y Medicina de la Mujer

  PRINCIPAL INVESTIGATOR

• Dr. Fernando Losa Domínguez, MD

  Clínica Sagrada Familia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Combalia, MD

CONTACT

+34 93 645 54 41; combalia.j@procarehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: December 12, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 31, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)