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VALOR: Vaginal Atrophy & Long-term Observation of Recovery

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Recruiting
18 years and older
Female
Phase N/A

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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.

Eligibility

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

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

NCT05953090

Stratpharma AG

18 February 2024

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