About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Protective Balm
Other interventionThe test product will be applied in addition to an additional washing product in the test area.
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
Global assessment of cosmetic efficacy by the physician
The physician will evaluate the global efficacy, according to a scale.
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).
Other outcomes
Assessment of urine incontinence
Assessment of urine incontinence according to ICIQ-SF questionnaire.
Assessment of fecal incontinence
Assessment of fecal incontinence according to CCFIS questionnaire.
Product use
Product is weighed before and after the application period
Sponsors and contacts
Click on the lead sponsor to view all of their trials.