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NCT Number: NCT06924502

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

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.

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Key information

Conditions

Incontinence, Urinary Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Incontinence, Fecal Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protective Balm

Other

The test product will be applied in addition to an additional washing product in the test area.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. 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).

  7. 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).

  8. 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).

Other outcomes

  1. Assessment of urine incontinence

    Time frame: Day 1

    Assessment of urine incontinence according to ICIQ-SF questionnaire.

  2. Assessment of fecal incontinence

    Time frame: Day 1

    Assessment of fecal incontinence according to CCFIS questionnaire.

  3. Product use

    Time frame: Day 15 ±2 (after 2 weeks of test product application)

    Product is weighed before and after the application period

Study contacts

Contact information is provided by the study sponsor or research team.

Clarissa Masur

CONTACT

[email protected]

Vanessa Letmathe

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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