VALOR: Vaginal Atrophy & Long-term Observation of Recovery (VALOR)

January 31, 2024 updated by: Stratpharma AG
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Active, not recruiting
        • Orange Coast Women's Medical Group
      • Los Alamitos, California, United States, 90720
        • Not yet recruiting
        • WR-PRI, LLC (Los Alamitos)
        • Principal Investigator:
          • Yasmin Herring, MD
        • Contact:
      • Newport Beach, California, United States, 92660
        • Recruiting
        • WR-PRI, LLC (Newport Beach)
        • Principal Investigator:
          • Susan Park, MD
        • Contact:
      • San Diego, California, United States, 92111
        • Not yet recruiting
        • WR-Women's Health Care Research, LLC
        • Contact:
        • Principal Investigator:
          • Robert Semo, MD
    • Florida
      • Lake City, Florida, United States, 32055
        • Not yet recruiting
        • WR-Multi-Specialty Research Associates
        • Contact:
        • Principal Investigator:
          • Cynthia Magrini, MD
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Not yet recruiting
        • WR-Mount Vernon Clinical Research, LLC
        • Principal Investigator:
          • Gretchen Mitchell, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Not yet recruiting
        • WR-Clinical Research Center of Nevada, LLC
        • Principal Investigator:
          • Liliana Ruiz-Leon, DO
        • Contact:
    • North Carolina
      • Fayetteville, North Carolina, United States, 28303
        • Recruiting
        • WR-Carolina Institute for Clinical Research
        • Principal Investigator:
          • Connette McMahon, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Not yet recruiting
        • WR-Charleston Clinical Trials, LLC
        • Principal Investigator:
          • Donald Hurley, DO
        • Contact:
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Southern Urogynecology
        • Contact:
        • Principal Investigator:
          • Andrea Pezzella, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38210
        • Not yet recruiting
        • WR-Medical Research Center of Memphis, LLC
        • Contact:
        • Principal Investigator:
          • Todd Chappell, MD
    • Texas
      • Dallas, Texas, United States, 75224
        • Recruiting
        • WR-Global Medical Research, LLC
        • Principal Investigator:
          • Roxanne Pero, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale
Time Frame: 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.
12 months
Change in patient-rated symptom severity assessed using a 10-point Likert scale.
Time Frame: 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.
12 months
Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.
Time Frame: 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.
12 months
Adverse Reactions
Time Frame: 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.
12 months
Product rating
Time Frame: 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.
12 months
Treatment adherence
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stratpharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPAMG03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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