What is the mechanism of action of this treatment?

Common treatments for Atrophic Vaginitis include protective barriers, moisturizers, and therapeutic delivery systems. Protective barriers shield sensitive vaginal tissues from irritation, while moisturizers hydrate the vaginal mucosa, improving elasticity and reducing dryness. Therapeutic delivery systems, such as novel gel dressings, offer localized treatment with minimal systemic absorption, making them suitable for patients who cannot use systemic hormone therapy. These mechanisms are essential for alleviating symptoms and improving the quality of life for Atrophic Vaginitis patients.

What side effects are associated with this type of intervention?

Common treatments for atrophic vaginitis, such as vaginal moisturizers and lubricants, are generally well-tolerated but may cause local irritation or allergic reactions. Estrogen therapy, which can be administered via creams, tablets, or rings, may lead to side effects including breast tenderness, vaginal spotting, and an increased risk of thromboembolic events.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrophic Vaginitis, primarily focusing on hormone replacement therapies such as estradiol creams, rings, and tablets that provide localized estrogen to alleviate symptoms. Non-hormonal options like moisturizers and lubricants, including products containing hyaluronic acid, have also been approved to provide relief through hydration and protective barriers. These treatments aim to restore vaginal moisture and elasticity, similar to the novel gel dressing being studied, which combines protective barrier properties, moisturization, and potential therapeutic delivery.

What other types of research exist?

Promising novel alternatives for atrophic vaginitis treatment in 2024 include: 1) Vaginal laser therapy, which stimulates collagen production and improves vaginal tissue health. 2) Hormonal treatments such as low-dose vaginal estrogen creams, rings, or tablets that provide localized hormone delivery. 3) Non-hormonal moisturizers and lubricants containing hyaluronic acid, which offer long-lasting hydration and tissue repair. 4) Vaginal probiotics that help maintain a healthy vaginal microbiome and reduce symptoms of atrophic vaginitis.

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Device

Gel Dressing 7-0940 for Vulvovaginal Atrophy (VALOR Trial)

N/A

Recruiting

Research Sponsored by Stratpharma AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus

Continuous vulvovaginal symptoms

Must not have

Unable to provide informed consent

Patient unable to apply topical device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new gel dressing on adult women with specific vulvovaginal skin conditions to see if it is safe and effective over time.

Who is the study for?

This trial is for adult women with vaginal atrophy, lichen sclerosus, lichen simplex chronicus or lichen planus who have ongoing symptoms. Participants need to have access to a smart device and email. Women using recent hormonal therapies, systemic corticosteroids, or those allergic to the gel's ingredients cannot join.

What is being tested?

The VALOR trial is testing a new gel dressing on female adults with certain vulvovaginal conditions. The study aims to evaluate both the immediate and long-term safety and effectiveness of this novel treatment option.

What are the potential side effects?

Potential side effects are not specified but may include skin reactions like irritation or allergy due to the ingredients in the gel dressing being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific skin or vaginal condition.

Select...

I have ongoing symptoms affecting my vulva or vagina.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and agree to the study's details on my own.

Select...

I cannot use skin-applied medical devices by myself.

Select...

I am currently using topical hormone replacement therapy or corticosteroids for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months

Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.

Secondary study objectives

Adverse Reactions

Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.

Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FeasibilityExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atrophic Vaginitis include protective barriers, moisturizers, and therapeutic delivery systems. Protective barriers shield sensitive vaginal tissues from irritation, while moisturizers hydrate the vaginal mucosa, improving elasticity and reducing dryness. Therapeutic delivery systems, such as novel gel dressings, offer localized treatment with minimal systemic absorption, making them suitable for patients who cannot use systemic hormone therapy. These mechanisms are essential for alleviating symptoms and improving the quality of life for Atrophic Vaginitis patients.

Therapeutic studies on vulvar vestibulitis.