a Flexible Wound Dressing for the Management of Genital Skin Conditions

The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients

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Key information

Conditions

Vaginitis Atrophic Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Lichen Planus Lichen Sclerosus Lichen Sclerosus et Atrophicus Lichenoid Eruptions Menopause Related Conditions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Urogenital Diseases Vaginal Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Andrews War Memorial Hospital

Spring Hill, Queensland, 4000, Australia

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 genital skin condition

Exclusion criteria

Unable to give informed consent
Patient unable to apply topical device
Allergy or intolerance to ingredients or excipients of the formulation of studied products

Treatment and study plan

Film forming silicone gel (7-0940)

Device

Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.

Primary outcomes

gynaecological skin condition

Time frame: Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months
Likert scales to measure:
- Dryness
- Tissue thinning
- Erosion/Ulcers
- Fissures
- Erythema
- Scarring/adhesion
- Contact bleeding
- Bloodblisters
- Greyish film
- White lacy streaks

Secondary outcomes

patient symptoms

Time frame: Duration of the therapy will be according to physician's clinical practice. The average is 3 visits over a period of 3 to 6 months
Likert scales to measure:
- Pruritus/itchiness
- Tender/sore
- Swelling
- Dryness
- Burning of skin
- Dyspareunia
- Stinging with urination/clothes
- Defecating pain/burning

Sponsors and collaborators

Lead sponsor

Stratpharma AG

Industry

Registry information

Official study title

Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: May 31, 2022
Registry last updated: May 31, 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.

Published trials that share one or more normalized conditions with this study.

Completed