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OpenTrials
Completed

NCT Number: NCT05432154

An Innovative 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

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Key information

Conditions

Atrophic Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Orange Coast Women's Medical Group

Laguna Hills, California, 92653, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Film forming silicone gel (7-0940)

Device

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.

Primary outcomes

  1. Patient-reported Vulvar Quality of Life

    Time frame: 3 months

    Vulvar Quality of Life Index

Secondary outcomes

  1. Patient-reported symptoms

    Time frame: 3 months

    Likert scales to measure:

    • Pruritus/itchiness
    • Tender/sore
    • Swelling
    • Dryness
    • Burning of skin
    • Dyspareunia
    • Stinging with urination/clothes
    • Defecating pain/burning

  2. Severity of overall condition

    Time frame: 3 months

    Clinician-rated severity of atrophic vaginitis

  3. Product rating

    Time frame: 3 months

    Likert scale for product rating by the patient

Sponsors and collaborators

Lead sponsor

Stratpharma AG

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2022
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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