RecruitingNot ApplicableNCT06924502

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


Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Enrollment

40 participants

Start Date

Jun 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 70 Years

Inclusion Criteria4

  • Patient is capable of understanding the information given to them and providing informed consent
  • 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 Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERProtective Balm

The test product will be applied in addition to an additional washing product in the test area.


Locations(1)

Klinikum Dortmund

Dortmund, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06924502


Related Trials