VALOR: Vaginal Atrophy & Long-term Observation of Recovery
VALOR
1 other identifier
interventional
2,000
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 20, 2026
February 1, 2026
4.6 years
March 29, 2023
February 19, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 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.
12 months
Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 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.
12 months
Secondary Outcomes (6)
Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale
12 months
Change in patient-rated symptom severity assessed using a 10-point Likert scale.
12 months
Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.
12 months
Adverse Reactions
12 months
Product rating
12 months
- +1 more secondary outcomes
Study Arms (1)
Feasibility
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stratpharma AGlead
Study Sites (14)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2023
First Posted
July 19, 2023
Study Start
October 30, 2023
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
February 20, 2026
Record last verified: 2026-02