VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Study Overview
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Brief Summary
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Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.

Official Title
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VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Conditions
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Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva, Lichen Planus of Vulva, Lichen Simplex of Vulva (Disorder)

Intervention / Treatment
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* Device: 7-0940


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus Continuous vulvovaginal symptoms Access to smartphone and tablet, laptop or computer Access to a valid email address Exclusion Criteria: Unable to provide informed consent Patient unable to apply topical device Allergy or intolerance to ingredients or excipients of the formulation of studied products Systemic hormonal therapy started less than 30 days before baseline Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline Ongoing topical HRT or corticosteroid treatment for the indication under investigation Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility<br> | Device: 7-0940<br>* A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.<br>* Other names: StrataMGT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months. | The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvovaginal Symptoms Questionnaire (VSQ) [min:0; max:16 (for sexually inactive patients) / max: 20 (for sexually active patients)]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VSQ score at 12 months. | 12 months | 
| Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months | The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvar Disease Quality of Life Index (VQLI). [min:0; max:45]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VQLI score at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale | Signs (dryness, tissue thinning, erosion, fissures, erythema, scarring, contact bleeding, labial fusion, labia reabsorption and contracture of posterior introitus) are rated by the investigator during a physical assessment at baseline and after 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible. | 12 months | 
| Change in patient-rated symptom severity assessed using a 10-point Likert scale. | Severity of symptoms (itch, burning, pain, irritation, dryness and pain during intercourse) are rated by the patient at baseline and at 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible. | 12 months | 
| Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale. | Severity of the visual pathology is rated by the investigator during baseline and after 12 months, using a 10-point Likert scale, ranging from 0=normal to 10=worst possible. Overall visual severity may include the severity of pathology at the Clitoral Hood, Urethra Area, Vaginal Vault, Labia Majora / Minora, Fourchette, Perineum, Perianal skin, Extragential site and/or Inguinal folds. | 12 months | 
| Adverse Reactions | Adverse reactions are rated by the investigator during baseline and after months 3, 6, 9, 12 months, using the dichotomous scale of presence and absence. | 12 months | 
| Product rating | Product performance is rated by the patient at the final visit after 12 months, using a Likert scale from 1=unsatisfactory to 5=excellent. | 12 months | 
| Treatment adherence | Treatment adherence is reported by the patient during the final study assessment, indicating the number of days/week and times/day the product was applied during the previous month. Percentage of treatment adherence is calculated from the minimum required treatment schedule. | 12 months |