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

Dr. August Wolff

Status: Enrolling

Conditions: Incontinence, Urinary; Incontinence, Fecal

Treatments: Other: Protective Balm

Study type: Interventional

Funder types: Industry

Identifiers

NCT06924502

GLS-02/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Test Product (P-001230/2)

Experimental group

Description:

Patients receive at least two applications of the test product P-001230/2 in the application area every day. An additional washing product is used to clean the skin.

Treatment:

Other: Protective Balm