Clinical trial NCT05888116: Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
Official title: Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Disease
Keywords: Vaginal Disease
Vaginal Dryness
Vaginal Atrophy
Lead sponsor: Dermofarm, S.A.U
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, randomized, controlled, double-blind study with two parallel group of subjects. The clinical investigation will be performed in 9 clinical sites.

The follow-up will be 4 weeks, with 3 face-to-face controls (baseline, 7 days and 30 days) and 2 telephone controls (3 days and 21 days).

At all on-site visits (baseline, Day 7, Day 30), the investigator will record the severity of patient-reported symptoms (via VAS of 0 to 100 mm) and perform a gynecological examination to evaluate signs of vaginal atrophy. Potential adverse events and potential device deficiencies will be recorded at each visit.

The patients will have a patient notebook where they will record the intensity of the symptoms on the third day and weekly, as well as the possible appearance of adverse events or product deficiencies.
Primary purpose: TREATMENT

Brief summary: 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®).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vaginal Health Index
timeFrame: At the end of study (Day 30)
Secondary outcomes:
measure: Severity of subjective symptoms (investigator record)
timeFrame: at 7 days and 30 days.
measure: Subjective symtomps (patient's notebook)
timeFrame: at 3 days, 7days, 14 days, 21 days and 30 days.
measure: Objective signs of vulvovaginal atrophy
timeFrame: at 7 days and 30 days.
measure: Vaginal pH
timeFrame: At the end of study (Day 30)
measure: Sexual function
timeFrame: At the end of study (Day 30)
measure: Global Symptom Score (GSS)
timeFrame: At the end of study (Day 30)
measure: Adverse events as a measure of Safety and Tolerability
timeFrame: At the end of study (Day 30)
measure: Overall Safety Assessment
timeFrame: At the end of study (Day 30)
measure: Patient satisfaction
timeFrame: At the end of study (Day 30)
Other outcomes:
Locations:
city: Tomelloso
country: Spain
facility: Corofas Menopause
state: Ciudad Real
Study officials:
affiliation: Clínica Corofas. Tomelloso. Ciudad Real
name: Maria Fasero, Ph
role: PRINCIPAL_INVESTIGATOR
References: