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An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

NCT05432154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-08-24

No results posted yet for this study

Summary

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

Conditions

  • Atrophic Vaginitis

Interventions

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.

Sponsors & Collaborators

  • Stratpharma AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05432154 on ClinicalTrials.gov