An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis

The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients

Study Overview

• Status: Completed
• Conditions: Atrophic Vaginitis
• Intervention / Treatment: Device: Film forming silicone gel (7-0940)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Orange Coast Women's Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Able to provide informed consent
• Diagnosed acute or chronic Atrophic Vaginitis
• Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT

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
• Currently on HRT (orally or topically)
• Currently on corticosteroid treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Treatment arm; Patients apply 7-0940 at least 2 times daily for 3 months.

Device: Film forming silicone gel (7-0940); Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Vulvar Quality of Life	Vulvar Quality of Life Index	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported symptoms	Likert scales to measure: Pruritus/itchiness; Tender/sore; Swelling; Dryness; Burning of skin; Dyspareunia; Stinging with urination/clothes; Defecating pain/burning	3 months
Severity of overall condition	Clinician-rated severity of atrophic vaginitis	3 months
Product rating	Likert scale for product rating by the patient	3 months

Collaborators and Investigators

• Sponsor: Stratpharma AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2022
• Primary Completion (ACTUAL): July 31, 2022
• Study Completion (ACTUAL): July 31, 2022

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (ACTUAL): June 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Vaginal Diseases; Vaginitis; Atrophic Vaginitis; Atrophy
• Other Study ID Numbers: SPAMG01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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