Recruiting

Observational Study

Sponsor:

Stratpharma AG

Code:

NCT05953090

Conditions

Atrophic Vaginitis

Vaginal Atrophy

Genitourinary Syndrome of Menopause

Lichen Sclerosus of Vulva

Lichen Planus of Vulva

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

7-0940

Study Details

Brief 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.

Conditions

Atrophic Vaginitis

Vaginal Atrophy

Genitourinary Syndrome of Menopause

Lichen Sclerosus of Vulva

Lichen Planus of Vulva

Study ID

NCT05953090

Start date

Oct 30, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

2000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Feasibility

Interventions

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.

Primary outcome measure

  • Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months. [ Time Frame: 12 months ]
  • Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Cahaba Dermatology & Skin Health Center

Recruiting

Birmingham, Alabama, United States, 35244

Contacts

Jennifer Perry

205 778-1564jperry@cahabaderm.com

Velvet Clinical Research

Recruiting

Burbank, California, United States, 91506

Contacts

Monica Torres

323-527-0907mtorres@velvetclinicalresearch.com

WR-PRI, LLC (Newport Beach)

Recruiting

Newport Beach, California, United States, 92660

Contacts

Diana Nguyen

(949) 752-7910dnguyen@wakeresearch.com

Principal Investigator:

Susan Park, MD

WR-Carolina Institute for Clinical Research

Recruiting

Fayetteville, North Carolina, United States, 28303

Contacts

Caitlyn Miller

(910) 302-8151cmiller@wakeresearch.com

Principal Investigator:

Connette McMahon, MD

Southern Urogynecology

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Tina McGready

803-457-7000tmcgready@southurogyn.com

Principal Investigator:

Andrea Pezzella, MD

WR-Global Medical Research, LLC

Recruiting

Dallas, Texas, United States, 75224

Contacts

Vicki Martinez

(469) 297-3074vmartinez@wakeresearch.com

Principal Investigator:

Roxanne Pero, MD

More Information

Sponsor

Stratpharma AG

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stratpharma AG on 2026-02-20.