VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Stratpharma

Status: Enrolling

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

Treatments: Device: 7-0940

Study type: Interventional

Funder types: Industry

Identifiers

NCT05953090

SPAMG03

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Feasibility

Experimental group

Treatment:

Device: 7-0940