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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05396261




Registration number
NCT05396261
Ethics application status
Date submitted
19/05/2022
Date registered
31/05/2022
Date last updated
31/05/2022

Titles & IDs
Public title
a Flexible Wound Dressing for the Management of Genital Skin Conditions
Scientific title
Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions
Secondary ID [1] 0 0
SPASMSX01 HALL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginitis 0 0
Atrophic Vaginitis 0 0
Lichen Planus 0 0
Lichen Sclerosus 0 0
Menopause Related Conditions 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Film forming silicone gel (7-0940)

Experimental: Treatment arm - 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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
gynaecological skin condition
Timepoint [1] 0 0
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 outcome [1] 0 0
patient symptoms
Timepoint [1] 0 0
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

Eligibility
Key inclusion criteria
* Able to provide informed consent
* Diagnosed genital skin condition
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2022
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
St. Andrews War Memorial Hospital - Spring Hill
Recruitment postcode(s) [1] 0 0
4000 - Spring Hill

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stratpharma AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
Trial website
https://clinicaltrials.gov/study/NCT05396261
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Hall, MD
Address 0 0
St. Andrews War Memorial Hospital - Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05396261