Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness (HYALU-LAUDE)

Dermofarm

Status: Completed

Conditions: Vaginal Disease

Treatments: Device: Cumlaude Hidrante Interno®; Device: Hidrante HA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05888116

DFARM-HYDRA-HA-2022

Details and patient eligibility

About

This study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).

Full description

This is a prospective, multicenter, randomized, controlled, double-blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid-based vaginal moisturizer gel (medical device class IIb) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (Cumluade Hidratante Interno®), with a 1-month follow-up.

The participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening.

The investigators will monitor the evolution of vaginal symptoms, vaginal health using the Vaginal Health Index (VHI), sexual function using the Female Sexual Function Index (FSFI) questionnaire, and the safety and tolerability of the new class IIb medical device.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women over 18 years of age who manifest subjective symptoms of vaginal dryness (dryness, itching, burning/stinging and dyspareunia).
• In the case of postmenopausal women, they must have a diagnosis confirmed by the gynecologist of the presence of signs of vulvovaginal dryness/atrophy (Vaginal Health Index score <15).
• Patients who have not used any topical treatment, moisturizer or vaginal lubricant for at least 7 days prior to the start of the study and agree not to use it during the study period.
• Patients who agree to participate and sign the Informed Consent form.

Exclusion criteria

• Pregnant women
• Malignant neoplasm within 5 years prior to study entry (except for treated basal cell/squamous cell carcinoma of the skin).
• Genital bleeding.
• Treatment with vaginal or systemic estrogens in the 3 months prior to study inclusion or during the study period. I said above
• Subjects with illness or other medical condition that, in the investigator's opinion, would compromise participation or could lead to hospitalization during the study.
• Clinical evidence of acute infection that requires treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e., tuberculosis), with the exception of HPV-carrying women with no lesions.
• Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except intermittent anxiety).
• Known allergy to the components of the investigational product or its excipients.
• Drug or alcohol abuse in the 12 months prior to the start of the study.
• Participation in an interventional clinical study or administration of any investigational agent within the previous 30 days.
• Patients with low expectation of compliance with the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Hidratante HA

Experimental group

Description:

The investigational product consists of a new vaginal moisturizing gel (class IIb medical device) presented in the form of 5 ml single-dose containers. Each patient will be given 12 single-dose containers inside white boxes identified only with the patient code. For each participant, the total duration of treatment will be 4 weeks.

Treatment:

Device: Hidrante HA

Cumlaude Hidratante Interno®

Active Comparator group

Description:

The investigational product is a marketed vaginal moisturizing gel (class IIb medical device) presented in the form of 5 ml single-dose containers. Each patient will be given 12 single-dose containers inside white boxes identified only with the patient code. For each participant, the total duration of treatment will be 4 weeks.

Treatment:

Device: Cumlaude Hidrante Interno®