a Flexible Wound Dressing for the Management of Genital Skin Conditions

Not Applicable

Completed

• Conditions: Atrophic Vaginitis; Lichen Planus; Menopause Related Conditions; Vaginitis; Lichen Sclerosus
• Interventions: Device: Film forming silicone gel (7-0940)

• Registration Number: NCT05396261
• Lead Sponsor: Stratpharma AG

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-31
• Primary Completion: 2022-01-01
• Study Completion: 2022-02-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	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.

Primary Outcome Measures

Name	Time	Method
gynaecological skin condition	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 Outcome Measures

Name	Time	Method
patient symptoms	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

Trial Locations

Locations (1)

St. Andrews War Memorial Hospital; 🇦🇺 Spring Hill, Queensland, Australia