About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 7-0940

Treatment groups

2,000 Participants
are divided into 1 treatment group

Locations

14
Alabama
Cahaba Dermatology & Skin Health Center35244, Birmingham United States
California
Velvet Clinical Research91506, Burbank United States
Orange Coast Women's Medical Group92653, Laguna Hills United States
WR-PRI, LLC (Los Alamitos)90720, Los Alamitos United States

Sponsors and collaborators

Stratpharma AG

Lead sponsor