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NCT05396261 Clinical Trial

a Flexible Wound Dressing for the Management of Genital Skin Conditions

Vaginitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05396261
Other study ID # SPASMSX01 HALL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2018
Est. completion date February 1, 2022

Study information
Verified date May 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 genital skin conditions in female patients

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date February 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Film forming silicone gel (7-0940)
Anecdotal evidence suggests that genital conditions in women associated with vaginal atrophy improve with the use of film-forming silicone dressings.

Locations
Country Name City State
Australia St. Andrews War Memorial Hospital Spring Hill Queensland

Sponsors (1)
Lead Sponsor Collaborator
Stratpharma AG

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary gynaecological skin condition Likert scales to measure:
Dryness
Tissue thinning
Erosion/Ulcers
Fissures
Erythema
Scarring/adhesion
Contact bleeding
Bloodblisters
Greyish film
White lacy streaks		 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
Secondary patient symptoms Likert scales to measure:
Pruritus/itchiness
Tender/sore
Swelling
Dryness
Burning of skin
Dyspareunia
Stinging with urination/clothes
Defecating pain/burning		 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
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