Vaginal DiseaseHYALU-LAUDENCT05888116
Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
A study testing Hidrante HA and Cumlaude Hidrante Interno® in people with Vaginal Disease, run by Dermofarm, S.A.U at 1 site in Spain.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Disease
- What is being tested?
- Hidrante HA and Cumlaude Hidrante Interno®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 23 May 2023to 18 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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®).
Read the 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.
- Conditions
- Vaginal Disease
- Being tested
- Hidrante HA, Cumlaude Hidrante Interno®
- Keywords
- Vaginal Disease, Vaginal Dryness, Vaginal Atrophy
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hidrante HADevice
Also called Experimental
Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.
Cumlaude Hidrante Interno®Device
Also called Active comparator
Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hidratante HA | Experimental | 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. Receives: Device: Hidrante HA |
| Cumlaude Hidratante Interno® | Active comparator | 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. Receives: Device: Cumlaude Hidrante Interno® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of study (Day 30)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of study (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start23 May 2023
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermofarm, S.A.U
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Fasero, Ph, Principal investigator, Clínica Corofas. Tomelloso. Ciudad Real
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888116
- Sponsor's protocol ID
- DFARM-HYDRA-HA-2022
- Acronym
- HYALU-LAUDE
- Status last verified
- Sep 2023
- First submitted
- 9 May 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05888116
- Acronym / sponsor ID
- HYALU-LAUDE / DFARM-HYDRA-HA-2022
- Conditions
- Vaginal Disease
- Keywords
- Vaginal Disease, Vaginal Dryness, Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dermofarm, S.A.UIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hidratante HA | Experimental | Device: Hidrante HAThe 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. |
| Cumlaude Hidratante Interno® | Active comparator | Device: Cumlaude Hidrante 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hidrante HAAlso: ExperimentalApply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks. | Device | Hidratante HA |
| Cumlaude Hidrante Interno®Also: Active comparatorApply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks. | Device | Cumlaude Hidratante Interno® |
Primary outcome
Vaginal Health Index
Time frame: At the end of study (Day 30)
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.
9 secondary outcomes
Severity of subjective symptoms (investigator record)
Time frame: at 7 days and 30 days.
Subjective symtomps (patient's notebook)
Time frame: at 3 days, 7days, 14 days, 21 days and 30 days.
Objective signs of vulvovaginal atrophy
Time frame: at 7 days and 30 days.
Vaginal pH
Time frame: At the end of study (Day 30)
Sexual function
Time frame: At the end of study (Day 30)
Global Symptom Score (GSS)
Time frame: At the end of study (Day 30)
Adverse events as a measure of Safety and Tolerability
Time frame: At the end of study (Day 30)
Overall Safety Assessment
Time frame: At the end of study (Day 30)
Patient satisfaction
Time frame: At the end of study (Day 30)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Fasero, Ph principal investigator
Clínica Corofas. Tomelloso. Ciudad Real
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hidrante HA and Cumlaude Hidrante Interno® in people with Vaginal Disease, run by Dermofarm, S.A.U at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Health Index (time frame: At the end of study (Day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.