a Flexible Wound Dressing for the Management of Genital Skin Conditions

Stratpharma AG54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vaginitis Atrophic Vaginitis Lichen Planus Lichen Sclerosus Menopause Related Conditions

Interventions

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

St. Andrews War Memorial Hospital

Spring Hill, Queensland, Australia

Outcomes

Primary Outcomes

gynaecological skin condition

Likert scales to measure: * Dryness * Tissue thinning * Erosion/Ulcers * Fissures * Erythema * Scarring/adhesion * Contact bleeding * Bloodblisters * Greyish film * White lacy streaks

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

Secondary Outcomes

patient symptoms

Likert scales to measure: * Pruritus/itchiness * Tender/sore * Swelling * Dryness * Burning of skin * Dyspareunia * Stinging with urination/clothes * Defecating pain/burning

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

Data from ClinicalTrials.gov

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