VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Description

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.

Conditions

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

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Study Overview

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Study Details

Study 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.

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Condition
Atrophic Vaginitis
Intervention / Treatment

-

Contacts and Locations

Laguna Hills

Orange Coast Women's Medical Group, Laguna Hills, California, United States, 92653

Los Alamitos

WR-PRI, LLC (Los Alamitos), Los Alamitos, California, United States, 90720

Newport Beach

WR-PRI, LLC (Newport Beach), Newport Beach, California, United States, 92660

San Diego

WR-Women's Health Care Research, LLC, San Diego, California, United States, 92111

Lake City

WR-Multi-Specialty Research Associates, Lake City, Florida, United States, 32055

Sandy Springs

WR-Mount Vernon Clinical Research, LLC, Sandy Springs, Georgia, United States, 30328

Las Vegas

WR-Clinical Research Center of Nevada, LLC, Las Vegas, Nevada, United States, 89106

Fayetteville

WR-Carolina Institute for Clinical Research, Fayetteville, North Carolina, United States, 28303

Charleston

WR-Charleston Clinical Trials, LLC, Charleston, South Carolina, United States, 29414

West Columbia

Southern Urogynecology, West Columbia, South Carolina, United States, 29169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stratpharma AG,

Study Record Dates

2026-12