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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2025
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedStudy Start
First participant enrolled
June 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJuly 18, 2025
July 1, 2025
5 months
April 4, 2025
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
Assessment of skin tolerability (single parameters) by the physician regarding erythema, oedema, dryness, papules or pustules
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
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
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
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
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
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
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
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 Outcomes (3)
Assessment of urine incontinence
Day 1
Assessment of fecal incontinence
Day 1
Product use
Day 15 ±2 (after 2 weeks of test product application)
Study Arms (1)
Test Product (P-001230/2)
EXPERIMENTALPatients 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.
Interventions
The test product will be applied in addition to an additional washing product in the test area.
Eligibility Criteria
You may qualify if:
- Patient is capable of understanding the information given to them and providing informed consent
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Dortmund
Dortmund, 33137, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Blinding of sponsor label (blanco primary packaging)
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2025
First Posted
April 11, 2025
Study Start
June 6, 2025
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
July 18, 2025
Record last verified: 2025-07