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

Not Applicable

Recruiting

• Conditions: Incontinence, Urinary; Incontinence, Fecal

• Registration Number: NCT06924502
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-10
• Study First Posted: 2025-04-11
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules	Day 1 vs Day 15±2 (after 2 weeks of test product application)	Single parameters (erythema, oedema, dryness, papules or pustules) will be assessed by a scale.
Assessment of product characteristics	Day 15 ±2 (after 2 weeks of test product application)	Product characteristics will be assessed by the patient in a questionnaire regarding sensation during application of the product by the nurse (feeling during application on the skin).
Global assessment of tolerability by the phyisician	Day 15 ±2 (after 2 weeks of test product application)	The physician will evaluate the global skin tolerability, according to a scale (taking results of skin tolerability (single parameters), and his or her personal assessment of tolerability at all time points into account).
Global assessment of cosmetic efficacy by the physician	Day 15 ±2 (after 2 weeks of test product application)	The physician will evaluate the global efficacy, according to a scale.
Assessment of skin condition by a nurse	Day 1 and Day 15 ±2 (after 2 weeks of test product application)	The skin condition (color, turgor and surface of the skin) will be assessed by binary queries (yes/no).; The caring and protecting status of the skin will be assessed by an Visual Analogue Scale (VAS).
Assessment of product characteristics by a nurse	Day 15 ±2 (after 2 weeks of test product application)	Product characteristics regarding scent, spreadability, removability, appearance of the skin (redness, dryness) will be assessed by a questionnaire with predefined answer options.
Global assessment of the product by a nurse	Day 15 ±2 (after 2 weeks of test product application)	The nurse will evaluate the global assessment of the product, according to a scale (taking results of the skin condition regarding the caring and protecting status and the product characteristics into account).
Assessment of skin tolerability by the patient	Day 15 ±2 (after 2 weeks of test product application)	The overall subjective skin status after application of the test product will be evaluated summarized for the whole application period according to a scale (each parameter (itching, burning, stinging, pain, soreness) separately).

Trial Locations

Locations (1)

Klinikum Dortmund; 🇩🇪 Dortmund, Germany