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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorDr. August Wolff GmbH & Co. KG Arzneimittel

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Protective Balm

    Other intervention

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Test Product (P-001230/2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1 vs Day 15±2 (after 2 weeks of test product application)
2

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).

Time frame
Day 15 ±2 (after 2 weeks of test product application)
3

Global assessment of cosmetic efficacy by the physician

The physician will evaluate the global efficacy, according to a scale.

Time frame
Day 15 ±2 (after 2 weeks of test product application)
4

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).

Time frame
Day 1 and Day 15 ±2 (after 2 weeks of test product application)

Secondary outcomes

Other outcomes

1

Assessment of urine incontinence

Assessment of urine incontinence according to ICIQ-SF questionnaire.

Time frame
Day 1
2

Assessment of fecal incontinence

Assessment of fecal incontinence according to CCFIS questionnaire.

Time frame
Day 1
3

Product use

Product is weighed before and after the application period

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

Sponsors and contacts

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