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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protective Balm | Other | The test product will be applied in addition to an additional washing product in the test area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of urine incontinence | Assessment of urine incontinence according to ICIQ-SF questionnaire. | Day 1 |
| Assessment of fecal incontinence | Assessment of fecal incontinence according to CCFIS questionnaire. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clarissa Masur | Contact | clarissa.masur@drwolffgroup.com | ||
| Vanessa Letmathe | Contact | vanessa.letmathe@drwolffgroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Dortmund | Recruiting | Dortmund | 33137 | Germany |
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Blinding of sponsor label (blanco primary packaging)
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| 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) |
| Day 1 |
| Product use | Product is weighed before and after the application period | Day 15 ±2 (after 2 weeks of test product application) |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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