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NCT05953090NARecruiting

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Stratpharma AG

Start Date

10/30/2023

Completion Date

12/1/2028

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

Age Range: 18 years to No maximum

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

Interventions

DEVICE

7-0940

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Conditions

Atrophic VaginitisVaginal AtrophyGenitourinary Syndrome of MenopauseLichen Sclerosus of VulvaLichen Planus of VulvaLichen Simplex of Vulva (Disorder)

Locations

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama 35244

United States

Velvet Clinical Research

Burbank, California 91506

United States

Orange Coast Women's Medical Group

Laguna Hills, California 92653

United States

WR-PRI, LLC (Los Alamitos)

Los Alamitos, California 90720

United States

WR-PRI, LLC (Newport Beach)

Newport Beach, California 92660

United States

WR-Women's Health Care Research, LLC

San Diego, California 92111

United States

WR-Multi-Specialty Research Associates

Lake City, Florida 32055

United States

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia 30328

United States

WR-Clinical Research Center of Nevada, LLC

Las Vegas, Nevada 89106

United States

WR-Carolina Institute for Clinical Research

Fayetteville, North Carolina 28303

United States

WR-Charleston Clinical Trials, LLC

Charleston, South Carolina 29414

United States

Southern Urogynecology

West Columbia, South Carolina 29169

United States

WR-Medical Research Center of Memphis, LLC

Memphis, Tennessee 38210

United States

WR-Global Medical Research, LLC

Dallas, Texas 75224

United States