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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05953090
Other study ID # SPAMG03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date December 2026

Study information

Verified date January 2024
Source Stratpharma AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
United States WR-Charleston Clinical Trials, LLC Charleston South Carolina
United States WR-Global Medical Research, LLC Dallas Texas
United States WR-Carolina Institute for Clinical Research Fayetteville North Carolina
United States Orange Coast Women's Medical Group Laguna Hills California
United States WR-Multi-Specialty Research Associates Lake City Florida
United States WR-Clinical Research Center of Nevada, LLC Las Vegas Nevada
United States WR-PRI, LLC (Los Alamitos) Los Alamitos California
United States WR-Medical Research Center of Memphis, LLC Memphis Tennessee
United States WR-PRI, LLC (Newport Beach) Newport Beach California
United States WR-Women's Health Care Research, LLC San Diego California
United States WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia
United States Southern Urogynecology West Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Stratpharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale 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
Secondary Change in patient-rated symptom severity assessed using a 10-point Likert scale. 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
Secondary Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale. 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
Secondary Adverse Reactions 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
Secondary Product rating 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
Secondary Treatment adherence 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
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