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

Primary Purpose

Vaginal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hidrante HA
Cumlaude Hidrante Interno®
Sponsored by
Dermofarm, S.A.U
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Disease focused on measuring Vaginal Disease, Vaginal Dryness, Vaginal Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Corofas MenopauseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hidratante HA

Cumlaude Hidratante Interno®

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 9, 2023
Last Updated
September 6, 2023
Sponsor
Dermofarm, S.A.U
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1. Study Identification

Unique Protocol Identification Number
NCT05888116
Brief Title
Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
Acronym
HYALU-LAUDE
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermofarm, S.A.U

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Disease
Keywords
Vaginal Disease, Vaginal Dryness, Vaginal Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
To maintain the double-blind, both the investigational and comparator products will be dispensed in white boxes, labeled with the study code and the patient code. Each patient code will be assigned to one treatment or the other according to a predetermined randomization list.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hidratante HA
Arm Type
Experimental
Arm 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.
Arm Title
Cumlaude Hidratante Interno®
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Hidrante HA
Other Intervention Name(s)
Experimental
Intervention Description
Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Cumlaude Hidrante Interno®
Other Intervention Name(s)
Active comparator
Intervention Description
Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.
Primary Outcome Measure Information:
Title
Vaginal Health Index
Description
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.
Time Frame
At the end of study (Day 30)
Secondary Outcome Measure Information:
Title
Severity of subjective symptoms (investigator record)
Description
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.
Time Frame
at 7 days and 30 days.
Title
Subjective symtomps (patient's notebook)
Description
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.
Time Frame
at 3 days, 7days, 14 days, 21 days and 30 days.
Title
Objective signs of vulvovaginal atrophy
Description
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.
Time Frame
at 7 days and 30 days.
Title
Vaginal pH
Description
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.
Time Frame
At the end of study (Day 30)
Title
Sexual function
Description
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.
Time Frame
At the end of study (Day 30)
Title
Global Symptom Score (GSS)
Description
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.
Time Frame
At the end of study (Day 30)
Title
Adverse events as a measure of Safety and Tolerability
Description
Number of participants with incidence of treatment-related adverse events, serious adverse events and device deficiencies as a Measure of Safety and Tolerability.
Time Frame
At the end of study (Day 30)
Title
Overall Safety Assessment
Description
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.
Time Frame
At the end of study (Day 30)
Title
Patient satisfaction
Description
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.
Time Frame
At the end of study (Day 30)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female can have vaginal disease.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulina Carvajal
Phone
+34 936026026
Email
pcarvajal@dermofarm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Montse Vidal, Ph
Phone
+34663825890
Email
montsevidal@crossdata.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fasero, Ph
Organizational Affiliation
Clínica Corofas. Tomelloso. Ciudad Real
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corofas Menopause
City
Tomelloso
State/Province
Ciudad Real
ZIP/Postal Code
13700
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Fasero, Ph
First Name & Middle Initial & Last Name & Degree
María Fasero

12. IPD Sharing Statement

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

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