VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Not Applicable

Recruiting

• Conditions: Vaginal Atrophy; Atrophic Vaginitis; Lichen Simplex of Vulva (Disorder); Lichen Sclerosus of Vulva; Lichen Planus of Vulva; Genitourinary Syndrome of Menopause
• Interventions: Device: 7-0940

• Registration Number: NCT05953090
• Lead Sponsor: Stratpharma AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-19
• Study Start: 2023-10-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility	7-0940	-

Primary Outcome Measures

Name	Time	Method
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.	12 months	The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvovaginal Symptoms Questionnaire (VSQ) \[min:0; max:16 (for sexually inactive patients) / max: 20 (for sexually active patients)\]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VSQ score at 12 months.
Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months	12 months	The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvar Disease Quality of Life Index (VQLI). \[min:0; max:45\]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VQLI score at 12 months.

Secondary Outcome Measures

Name	Time	Method
Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale	12 months	Signs (dryness, tissue thinning, erosion, fissures, erythema, scarring, contact bleeding, labial fusion, labia reabsorption and contracture of posterior introitus) are rated by the investigator during a physical assessment at baseline and after 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible.
Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.	12 months	Severity of the visual pathology is rated by the investigator during baseline and after 12 months, using a 10-point Likert scale, ranging from 0=normal to 10=worst possible. Overall visual severity may include the severity of pathology at the Clitoral Hood, Urethra Area, Vaginal Vault, Labia Majora / Minora, Fourchette, Perineum, Perianal skin, Extragential site and/or Inguinal folds.
Treatment adherence	12 months	Treatment adherence is reported by the patient during the final study assessment, indicating the number of days/week and times/day the product was applied during the previous month. Percentage of treatment adherence is calculated from the minimum required treatment schedule.
Change in patient-rated symptom severity assessed using a 10-point Likert scale.	12 months	Severity of symptoms (itch, burning, pain, irritation, dryness and pain during intercourse) are rated by the patient at baseline and at 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible.
Adverse Reactions	12 months	Adverse reactions are rated by the investigator during baseline and after months 3, 6, 9, 12 months, using the dichotomous scale of presence and absence.
Product rating	12 months	Product performance is rated by the patient at the final visit after 12 months, using a Likert scale from 1=unsatisfactory to 5=excellent.

Trial Locations

Locations (12)

Southern Urogynecology; 🇺🇸 West Columbia, South Carolina, United States

WR-Clinical Research Center of Nevada, LLC; 🇺🇸 Las Vegas, Nevada, United States

WR-Charleston Clinical Trials, LLC; 🇺🇸 Charleston, South Carolina, United States

WR-Medical Research Center of Memphis, LLC; 🇺🇸 Memphis, Tennessee, United States

Orange Coast Women's Medical Group; 🇺🇸 Laguna Hills, California, United States

WR-PRI, LLC (Los Alamitos); 🇺🇸 Los Alamitos, California, United States

WR-Mount Vernon Clinical Research, LLC; 🇺🇸 Sandy Springs, Georgia, United States

WR-Women's Health Care Research, LLC; 🇺🇸 San Diego, California, United States

WR-Multi-Specialty Research Associates; 🇺🇸 Lake City, Florida, United States

WR-Carolina Institute for Clinical Research; 🇺🇸 Fayetteville, North Carolina, United States

WR-Global Medical Research, LLC; 🇺🇸 Dallas, Texas, United States

WR-PRI, LLC (Newport Beach); 🇺🇸 Newport Beach, California, United States