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

NCT05888116 | Completed

• 1 other identifier: DFARM-HYDRA-HA-2022
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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®).

Conditions

Vaginal Disease

Keywords

Vaginal Disease; Vaginal Dryness; Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Severity of subjective symptoms (investigator record)

  at 7 days and 30 days.

• Subjective symtomps (patient's notebook)

  at 3 days, 7days, 14 days, 21 days and 30 days.

• Objective signs of vulvovaginal atrophy

  at 7 days and 30 days.

• Vaginal pH

  At the end of study (Day 30)

• Sexual function

  At the end of study (Day 30)

Study Arms (2)

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.

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.

Device: Cumlaude Hidrante Interno®

Interventions

Hidrante HA DEVICE

Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.

Also known as: Experimental

Hidratante HA

Cumlaude Hidrante Interno® DEVICE

Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.

Also known as: Active comparator

Cumlaude Hidratante Interno®

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female can have vaginal disease.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women
• Malignant neoplasm within 5 years prior to study entry (except for treated basal cell/squamous cell carcinoma of the skin).
• Genital bleeding.
• 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.

Sponsors & Collaborators

• Dermofarm, S.A.U: lead

Study Sites (1)

Corofas Menopause

Tomelloso, Ciudad Real, 13700, Spain

Location

MeSH Terms

Conditions

Vaginal Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Maria Fasero, Ph

  Clínica Corofas. Tomelloso. Ciudad Real

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 5, 2023
• Study Start: May 23, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-09

Locations

ES (1)