An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

Stratpharma

Status: Completed

Conditions: Atrophic Vaginitis

Treatments: Device: Film forming silicone gel (7-0940)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05432154

SPAMG01

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment arm

Experimental group

Description:

Patients apply 7-0940 at least 2 times daily for 3 months.

Treatment:

Device: Film forming silicone gel (7-0940)