Status:
RECRUITING
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
Lead Sponsor:
Dr. August Wolff GmbH & Co. KG Arzneimittel
Conditions:
Incontinence, Urinary
Incontinence, Fecal
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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 ski...
Eligibility Criteria
Inclusion
- Patient is capable of understanding the information given to them and providing informed consent
- 70 years of age and older
- Patients with incontinence (fecal and/or urinary), requiring incontinence protection material
- Skin type on Fitzpatrick scale: Between I to IV
Exclusion
- Current cancer treatment such as chemotherapy, irradiation
- Documented allergies to skin care and / or skin cleansing products
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- Incontinence-associated dermatitis (IAD) stage \>1a
- Active skin disease at the test area
- Any topical medication at the test area within the last 3 days prior to the start of the study and / or hroughout te entire course of the study
- Mini-Mental-Status-Test (MMST) \< 20
Key Trial Info
Start Date :
June 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06924502
Start Date
June 6 2025
End Date
November 1 2025
Last Update
July 18 2025
Active Locations (1)
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1
Klinikum Dortmund
Dortmund, Germany, 33137