NCT06924502

Testing the Protective and Caring Effect of a Water-in-oil Formulation in Patients Suffering From Urinary and/or Fecal Incontinence and Requiring Incontinence Care Products

Non-controlled, Exploratory, Single-arm Clinical Study With a Water-in-oil Emulsion to Test the Protecting and Caring Effect of the Formulation on 'Incontinence-care Product Requiring' Fecal and/or Urinary Incontinent Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.

Detailed description

Patients receive at least two applications of the test product in the application area daily for two weeks. An additional washing product is used during the entire application time. The caring and skin protecting effects, the skin tolerability and cosmetic efficacy of the test product will be assessed by a physician, a nurse and the patient.

Conditions

• Incontinence, Urinary
• Incontinence, Fecal

Interventions

Type	Name	Description
OTHER	Protective Balm	The test product will be applied in addition to an additional washing product in the test area.

Timeline

• Start date: 2025-06-06
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-04-11
• Last updated: 2025-07-18

Locations

1 site across 1 country: Germany