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

July 17, 2025 updated by: Dr. August Wolff GmbH & Co. KG Arzneimittel

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Product (P-001230/2)
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.
Other: Protective Balm
The test product will be applied in addition to an additional washing product in the test area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules
Time Frame: 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.
Day 1 vs Day 15±2 (after 2 weeks of test product application)
Global assessment of tolerability by the phyisician
Time Frame: 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).
Day 15 ±2 (after 2 weeks of test product application)
Global assessment of cosmetic efficacy by the physician
Time Frame: Day 15 ±2 (after 2 weeks of test product application)
The physician will evaluate the global efficacy, according to a scale.
Day 15 ±2 (after 2 weeks of test product application)
Assessment of skin condition by a nurse
Time Frame: 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).
Day 1 and Day 15 ±2 (after 2 weeks of test product application)
Assessment of product characteristics by a nurse
Time Frame: 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.
Day 15 ±2 (after 2 weeks of test product application)
Global assessment of the product by a nurse
Time Frame: 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).
Day 15 ±2 (after 2 weeks of test product application)
Assessment of product characteristics
Time Frame: 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).
Day 15 ±2 (after 2 weeks of test product application)
Assessment of skin tolerability by the patient
Time Frame: 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).
Day 15 ±2 (after 2 weeks of test product application)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of urine incontinence
Time Frame: Day 1
Assessment of urine incontinence according to ICIQ-SF questionnaire.
Day 1
Assessment of fecal incontinence
Time Frame: Day 1
Assessment of fecal incontinence according to CCFIS questionnaire.
Day 1
Product use
Time Frame: Day 15 ±2 (after 2 weeks of test product application)
Product is weighed before and after the application period
Day 15 ±2 (after 2 weeks of test product application)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLS-02/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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