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

Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness

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®).

Study Overview

• Status: Completed
• Conditions: Vaginal Disease
• Intervention / Treatment: Device: Hidrante HA; Device: Cumlaude Hidrante 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Montse Vidal, Ph; Phone Number: +34663825890; Email: montsevidal@crossdata.es
• Study Contact Backup: Name: Paulina Carvajal; Phone Number: +34 936026026; Email: pcarvajal@dermofarm.com

Study Locations

• Spain
  • Ciudad Real
    • Tomelloso, Ciudad Real, Spain, 13700
      • Corofas Menopause
      • Contact: María Fasero, Ph
      • Principal Investigator: María Fasero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hidratante HA; 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.	Device: Hidrante HA; Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.; Other Names: Experimental
Active Comparator: Cumlaude Hidratante Interno®; 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.	Device: Cumlaude Hidrante Interno®; Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.; Other Names: Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Health Index	The Vaginal Health Index ranges from a minimum of 5 to a maximum of 25. The change will be assessed by comparing scores from baseline to 30 days (final visit); with comparison intra and inter groups.	At the end of study (Day 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of subjective symptoms (investigator record)	Severity of dryness, itching, burning and dyspareunia reported by the investigator in the data registration form, assessed using a visual analog scale (VAS from 0=none to 10=maximum).The change will be assessed by comparing scores from baseline to day 7 and to day 30; with comparison intra and inter groups.	at 7 days and 30 days.
Subjective symtomps (patient's notebook)	Severity of dryness, itching, burning and dyspareunia reported on patient diary using a 4-point Likert scales (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The change will be assessed by comparing scores from baseline to every record (3 days, 7days, 14 days, 21 days and 30 days); with comparison intra and inter groups.	at 3 days, 7days, 14 days, 21 days and 30 days.
Objective signs of vulvovaginal atrophy	Objective signs of vulvovaginal atrophy (dryness, flattening of folds, mucosal pallor, frailty and petechiae) reported by the investigator in the data registration form, assessed using a 4-point Likert scales (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The change will be assessed by comparing scores from baseline to day 7 and to day 30; with comparison intra and inter groups.	at 7 days and 30 days.
Vaginal pH	Vaginal pH will be measured by the investigator with a test strip delivered by sponsor. The change will be assessed by comparing pH values from baseline to day 30; with comparison intra and inter groups.	At the end of study (Day 30)
Sexual function	Female Sexual Function Index (FSFI) questionnaire will be answered by the patients at the baseline and 30-day visits. The change will be assessed by comparing FSFI scores from baseline to day 30; with comparison intra and inter groups.	At the end of study (Day 30)
Global Symptom Score (GSS)	Global Symptom Score (GSS) will be assessed by the sum of severity scores of each symptom: dryness, itching, burning/stinging and dyspareunia (0 = none, 1 = mild, 2 = moderate and 3 = severe). GSS score ranges from 0 to 12. The change will be assessed by comparing GSS scores from baseline to day 30; with comparison intra and inter groups.	At the end of study (Day 30)
Overall Safety Assessment	Overall patient and investigator safety rating, using 4-point Likert-type scale (1 = very good, 2 = good, 3 = moderate, 4 = poor, 5=very poor); with comparison inter groups.	At the end of study (Day 30)
Patient satisfaction	The patient's degree of satisfaction with the product will be rated using a 5-point Likert-type scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5=very dissatisfied); with comparison inter groups.	At the end of study (Day 30)
Adverse events as a measure of Safety and Tolerability	Number of participants with incidence of treatment-related adverse events, serious adverse events and device deficiencies as a Measure of Safety and Tolerability.	At the end of study (Day 30)

Collaborators and Investigators

• Sponsor: Dermofarm, S.A.U
• Investigators: Principal Investigator: Maria Fasero, Ph, Clínica Corofas. Tomelloso. Ciudad Real

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Vaginal Atrophy; Vaginal Dryness; Vaginal Disease
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases
• Other Study ID Numbers: DFARM-HYDRA-HA-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No