a Flexible Wound Dressing for the Management of Genital Skin Conditions

May 24, 2022 updated by: Stratpharma AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Spring Hill, Queensland, Australia, 4000
        • St. Andrews War Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stratpharma AG

Investigators

  • Principal Investigator: Philip Hall, MD, St. Andrews War Memorial Hospital - Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPASMSX01 HALL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaginitis

Clinical Trials on Film forming silicone gel (7-0940)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe