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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Feasibility
  • Device: 7-0940
    A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.
    Other names:
    • StrataMGT

Recruiting Locations

WR-PRI, LLC (Newport Beach)
Newport Beach, California 92660
Contact:
Diana Nguyen
(949) 752-7910
dnguyen@wakeresearch.com

WR-Carolina Institute for Clinical Research
Fayetteville, North Carolina 28303
Contact:
Caitlyn Miller
(910) 302-8151
cmiller@wakeresearch.com

Southern Urogynecology
West Columbia, South Carolina 29169
Contact:
Tina McGready
803-457-7000
tmcgready@southurogyn.com

WR-Global Medical Research, LLC
Dallas, Texas 75224
Contact:
Vicki Martinez
(469) 297-3074
vmartinez@wakeresearch.com

More Details

NCT ID
NCT05953090
Status
Recruiting
Sponsor
Stratpharma AG

Notice

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