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
NCT ID: NCT06924502
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-06
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Incontinence Associated Dermatitis - Automated
NCT03046810
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
NCT02428595
Maintaining Lower Levels of Care Through Automated Perineal Hygiene
NCT03051321
Autologous Muscle Derived Cells for Underactive Bladder
NCT02463448
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
NCT01648491
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Protective Balm
The test product will be applied in addition to an additional washing product in the test area.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Protective Balm
The test product will be applied in addition to an additional washing product in the test area.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. August Wolff GmbH & Co. KG Arzneimittel
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinikum Dortmund
Dortmund, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GLS-02/2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.