Testing a protective balm for patients with urinary and fecal incontinence
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
NA · Dr. August Wolff GmbH & Co. KG Arzneimittel · NCT06924502
This study is testing a new protective balm to see if it helps people with urinary and fecal incontinence keep their skin healthy and comfortable.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Dr. August Wolff GmbH & Co. KG Arzneimittel (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dortmund) |
| Trial ID | NCT06924502 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the protective and caring effects of a water-in-oil formulation balm on patients suffering from urinary and/or fecal incontinence. Participants will apply the balm at least twice daily for two weeks, alongside a washing product. The study will assess the balm's skin tolerability, protective effects, and cosmetic efficacy through evaluations by physicians, nurses, and the patients themselves.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 70 and older who experience urinary and/or fecal incontinence and require incontinence care products.
Not a fit: Patients currently undergoing cancer treatment or those with active skin diseases or severe skin conditions at the test area may not benefit from this study.
Why it matters
Potential benefit: If successful, this balm could significantly improve the quality of life for patients dealing with incontinence by providing better skin protection and care.
How similar studies have performed: While this specific formulation is novel, similar studies have shown positive outcomes in improving skin care for incontinence patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dortmund
- Klinikum Dortmund — Dortmund, Germany (RECRUITING)
Study contacts
- Study coordinator: Clarissa Masur
- Email: clarissa.masur@drwolffgroup.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Incontinence, Urinary, Incontinence, Fecal