Clinical trial NCT05953090: VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Official title: VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophic Vaginitis
Vaginal Atrophy
Genitourinary Syndrome of Menopause
Lichen Sclerosus of Vulva
Lichen Planus of Vulva
Lichen Simplex of Vulva (Disorder)
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2023-07-19
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.
timeFrame: 12 months
measure: Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale
timeFrame: 12 months
measure: Change in patient-rated symptom severity assessed using a 10-point Likert scale.
timeFrame: 12 months
measure: Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.
timeFrame: 12 months
measure: Adverse Reactions
timeFrame: 12 months
measure: Product rating
timeFrame: 12 months
measure: Treatment adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange Coast Women's Medical Group
state: California
city: Los Alamitos
country: United States
facility: WR-PRI, LLC (Los Alamitos)
state: California
city: Newport Beach
country: United States
facility: WR-PRI, LLC (Newport Beach)
state: California
city: San Diego
country: United States
facility: WR-Women's Health Care Research, LLC
state: California
city: Lake City
country: United States
facility: WR-Multi-Specialty Research Associates
state: Florida
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Las Vegas
country: United States
facility: WR-Clinical Research Center of Nevada, LLC
state: Nevada
city: Fayetteville
country: United States
facility: WR-Carolina Institute for Clinical Research
state: North Carolina
city: Charleston
country: United States
facility: WR-Charleston Clinical Trials, LLC
state: South Carolina
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Memphis
country: United States
facility: WR-Medical Research Center of Memphis, LLC
state: Tennessee
city: Dallas
country: United States
facility: WR-Global Medical Research, LLC
state: Texas
Study officials:
References: