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NCT05432154 Clinical Trial

An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

Atrophic Vaginitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05432154
Other study ID # SPAMG01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date July 31, 2022

Study information
Verified date August 2022
Source Stratpharma AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Orange Coast Women's Medical Group Laguna Hills California

Sponsors (1)
Lead Sponsor Collaborator
Stratpharma AG

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient-reported Vulvar Quality of Life Vulvar Quality of Life Index 3 months
Secondary 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
Secondary Severity of overall condition Clinician-rated severity of atrophic vaginitis 3 months
Secondary Product rating Likert scale for product rating by the patient 3 months
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