Incontinence Associated Dermatitis (IAD) and incontinence care
Conditions
Interventions
Group 1: MoliCare® Premium Form 4 drops and cellulose pads
MoliCare® Premium Form 4 drops, the test product, contains cellulose, superabsorbent polymer, and nonwoven materials (polyethylene and polyp
Sponsors
PAUL HARTMANN AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Healthy skin in the test area • Uniform skin colour and no erythema or dark pigmentation in the test area • Written Informed Consent to participate in the study • Willingness to actively participate in the study and to come to the scheduled visits • The subjects must be able to communicate with the attending study nurse or the attending dermatologist and to understand and follow up the requirements of this clinic-dermatological application study.
Exclusion criteria
Exclusion criteria: • Severe or chronic skin inflammations • Taking of drugs that may interfere with skin reactions (glucocorticoids, antiallergics, topical immune modulators, etc.) • Application of active substance-containing products and care products 7-10 days before the start of the test • Severe allergies or any serious side effects of cosmetic preparations ever occurred • Sun baths or solarium visits during the study • Female subjects: Pregnancy or lactation • Drug addicts, alcoholics • AIDS, HIV-positive or infectious hepatitis • Conditions which exclude a participation or might influence the test reaction/evaluation • Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years • Severe internal or chronic diseases • One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases • Intolerability against adhesive dressings (e.g. acrylate) • Active skin disease at the test area • Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study • Any topical medication at the test area within the last 3 days prior to the start of the study and/or throughout the entire course of the study • Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of efficacy: • Transepidermal water loss (TEWL) measured by Tewameter [g/(m2h)] on the volar forearms of 75 healthy volunteers from an alkaline pH 10.7 challenge for 6 hours. • Skin colour/erythema score readings (spectrophotometry) measured on the volar forearms of 75 healthy volunteers from an alkaline pH 10.7 challenge for 6 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of skin tolerability: From the time of the start of the study to the end of the study and 30 days beyond, all skin reactions and any other adverse reactions are recorded in the reaction file | — |
Countries
Germany
Contacts
Public ContactHans Smola
Outcome results
None listed