a Flexible Wound Dressing for the Management of Genital Skin Conditions

Overview

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

Full Title of Study: “Post-marketing Surveillance of a Flexible Wound Dressing for the Management of Genital Skin Conditions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stratpharma AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philip Hall, MD, Principal Investigator, St. Andrews War Memorial Hospital – Australia

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