Incontinence, UrinaryNCT06924502
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
A study testing Protective Balm in people with Incontinence, Urinary and Incontinence, Fecal, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Incontinence, Urinary, Incontinence, Fecal
- What is being tested?
- Protective Balm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2025to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Incontinence, Urinary, Incontinence, Fecal
- Being tested
- Protective Balm
- Medical subject headings
- Urinary Incontinence, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective BalmOther
The test product will be applied in addition to an additional washing product in the test area.
| Study group | Role | What they receive |
|---|---|---|
| Test Product (P-001230/2) | Experimental | 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. Receives: Other: Protective Balm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 15 ±2 (after 2 weeks of test product application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start6 Jun 2025
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924502
- Sponsor's protocol ID
- GLS-02/2024
- Status last verified
- Jul 2025
- First submitted
- 4 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06924502
- Acronym / sponsor ID
- GLS-02/2024
- Conditions
- Incontinence, Urinary, Incontinence, Fecal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Product (P-001230/2) | Experimental | Other: Protective BalmPatients 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective BalmThe test product will be applied in addition to an additional washing product in the test area. | Other | Test Product (P-001230/2) |
Primary outcome
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.
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).
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.
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).
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.
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective Balm in people with Incontinence, Urinary and Incontinence, Fecal, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.