Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incontinence, Urinary
Incontinence, Fecal
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
First posted: 2025-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 skin protecting effects, the skin tolerability and cosmetic efficacy of the test product will be assessed by a physician, a nurse and the patient.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules
timeFrame: Day 1 vs Day 15±2 (after 2 weeks of test product application)
measure: Global assessment of tolerability by the phyisician
timeFrame: Day 15 ±2 (after 2 weeks of test product application)
measure: Global assessment of cosmetic efficacy by the physician
timeFrame: Day 15 ±2 (after 2 weeks of test product application)
measure: Assessment of skin condition by a nurse
timeFrame: Day 1 and Day 15 ±2 (after 2 weeks of test product application)
measure: Assessment of product characteristics by a nurse
timeFrame: Day 15 ±2 (after 2 weeks of test product application)
measure: Global assessment of the product by a nurse
timeFrame: Day 15 ±2 (after 2 weeks of test product application)
measure: Assessment of product characteristics
timeFrame: Day 15 ±2 (after 2 weeks of test product application)
measure: Assessment of skin tolerability by the patient
timeFrame: Day 15 ±2 (after 2 weeks of test product application)
Secondary outcomes:
Other outcomes:
measure: Assessment of urine incontinence
timeFrame: Day 1
measure: Assessment of fecal incontinence
timeFrame: Day 1
measure: Product use
timeFrame: Day 15 ±2 (after 2 weeks of test product application)
Locations:
city: Dortmund
country: Germany
facility: Klinikum Dortmund
Study officials:
References: