VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Stratpharma AG2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

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

Interventions

7-0940DEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Orange Coast Women's Medical Group

Laguna Hills, California, United States

ACTIVE_NOT_RECRUITING

WR-PRI, LLC (Los Alamitos)

Los Alamitos, California, United States

NOT_YET_RECRUITING

WR-PRI, LLC (Newport Beach)

Newport Beach, California, United States

RECRUITING

WR-Women's Health Care Research, LLC

San Diego, California, United States

NOT_YET_RECRUITING

WR-Multi-Specialty Research Associates

Lake City, Florida, United States

NOT_YET_RECRUITING

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

NOT_YET_RECRUITING

WR-Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, United States

NOT_YET_RECRUITING

WR-Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

RECRUITING

WR-Charleston Clinical Trials, LLC

Charleston, South Carolina, United States

NOT_YET_RECRUITING

Southern Urogynecology

West Columbia, South Carolina, United States

RECRUITING

...and 2 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months