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

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.

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.

Inclusion Criteria:

• 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 Criteria:

• 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