An interventional study of ESENTA™ Skin Barrier Spray (ConvaTec, UK) and Hydrophobes Basisgel DAC in Incontinence-associated Dermatitis, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Prevention
Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged direct contact of the skin with urine and/or stool. Elderly and care-dependent people are often affected by this type of inflammation. Gentle skin cleansing and the use of skin protection products are recommended. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. There is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory trial in elderly nursing home residents and geriatric patients will be conducted.
Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged and direct contact of the skin with urine and/or stool. It may occur in all age groups but elderly and care-dependent incontinent people are often affected by this type of inflammation. Promotion of continence, use of absorbent products and structured skin care are recommended to prevent and/or treat IAD. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. Currently, there is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory randomized controlled trial in incontinent elderly nursing home residents and geriatric patients will be conducted. In the two intervention groups, a film-forming or a lipophilic skin protection product will be applied in addition to standardized skin care regimens. Every other day, investigators will perform skin inspections, including instrumental skin measurements to quantify erythema for a total study period of n= 14 days. IAD- related pain and itch will be assessed. A total of n= 210 nursing home residents and geriatric patients in Berlin, Germany, aged over 65 years, who are affected by urinary and faecal incontinence without signs of severe IAD will be included.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 220 is above the median of 50 across 114 interventional studies indexed under Erythema.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the intervention group I, standardized mild skin cleansing regimen and daily topical application of a film-forming skin protectant at the exposed skin areas will be applied by nursing staff.
Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)
In the intervention group II, standardized mild skin cleansing regimen and daily topical application of a hydrophobic skin protectant at the exposed skin areas will be applied by nursing staff.
Other: Hydrophobes Basisgel DAC
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
The skin protectant will be applied on clean and dry skin exposed to urine and stool. After application, the solvent evaporates leaving a silicone film on the skin surface.
Also known as: Film-forming skin protectant
The skin protectant will be applied on clean and dry skin. It contains 95% paraffin oil and creates a hydrophobic layer on the skin surface.
Also known as: Hydrophobic skin protectant
Incidence of Incontinence-associated Dermatitis (IAD)
Number of subjects developing IAD of all subjects (cumulative incidence). Classification of IAD according to Ghent Global IAD Categorisation Tool (GLOBIAD) (Category 1A, 1B, 2A, 2B). The GLOBIAD categorises IAD severity based on visual inspection of the affected skin areas. Category 1A: Persistent redness without clinical signs of infection Category 1B: Persistent redness with clinical signs of infection Category 2A: Skin loss without clinical signs of infection Category 2B: Skin loss with clinical signs of infection
Time frame: 14 Days
Erythema (Instrumental Measurement)
Erythema measured with the Mexameter MX® 18 (Courage + Khazaka, Cologne, Germany). Means of two duplicate measurements per skin area are displayed in arbitrary units (AU) ranging from 0 (= no erythema) to 999 (= extreme erythema).
Time frame: 14 Days
Erythema (Visual Inspection)
Clinical rating of erythema is conducted according to the item 'Redness' of the incontinence-associated dermatitis and its severity (IADS) instrument. The 3-Item-Scale describes 'Redness' as (1) none, (2) pink, (3) red/ bright red.
Time frame: 14 Days
Incidence of Erosion
The presence (no or yes) of erosion is defined according to the latest International League of Dermatological Societies glossary of cutaneous lesions as a loss of either a portion of or the entire epidermis. Number of subjects developing erosions of all subjects (cumulative incidence).
Time frame: 14 Days
Incidence of Maceration
The presence (no or yes) of maceration is defined as the result of prolonged exposure (of the skin) to moisture and causes the skin to soften and breakdown so that the connective fibres can be teased apart and the skin often exhibits a white appearance. Number of subjects developing maceration of all subjects (cumulative incidence).
Time frame: 14 Days
IAD Related Pain
Numeric Rating Scale (NRS) pain score. The NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity. The NRS was administered only to participants without cognitive impairment (MMSE ≥24).
Time frame: 14 Days
Incidence of IAD Related Itch
IAD related itch will be reported directly by patients (yes or no). Number of subjects reporting itch of all subjects (cumulative incidence).
Time frame: 14 Days
Presence of Local Intolerances
The presence of local intolerances will be assessed with the following options: (0) None; 1. homogeneous redness with scattered papules; 2. homogeneous redness and homogeneous infiltration 3. homogeneous redness and infiltration with vesicles 4. homogeneous redness and infiltration with coalescing vesicles
Time frame: 14 Days
Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs and SAEs will be documented and reported according to the current regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) Article 2.
Time frame: 14 Days
Incidents and Serious Incidents
Incidents abd serious incidents will be documented according to the definition of the EU regulation 2017/745 MDR Article 2 and reported to the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
Time frame: 14 Days
The study was conducted in the federal state of Berlin, Germany. Recruitment and study procedures took place in 20 geriatric care units, including two inpatient wards in acute care hospitals and 18 long-term care facilities. Participant recruitment was conducted from August 2022 to January 2025, and follow-up for all study outcomes, including potential harms, was completed in February 2025.
| Milestone | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Started | 57 | 57 | 53 |
| Per-protocol | 53 | 49 | 53 |
| Completed | 57 | 57 | 53 |
| Not completed | 0 | 0 | 0 |
Number of subjects developing IAD of all subjects (cumulative incidence). Classification of IAD according to Ghent Global IAD Categorisation Tool (GLOBIAD) (Category 1A, 1B, 2A, 2B). The GLOBIAD categorises IAD severity based on visual inspection of the affected skin areas. Category 1A: Persistent redness without clinical signs of infection Category 1B: Persistent redness with clinical signs of infection Category 2A: Skin loss without clinical signs of infection Category 2B: Skin loss with clinical signs of infection
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Incidence IAD 1 and/or 2 | 18 | 8 | 5 |
| Incidence IAD 2A/B | 5 | 3 | 2 |
| No IAD at baseline → IAD 1A/B | 15 | 6 | 5 |
| No IAD at baseline → IAD 2A/B | 3 | 2 | 0 |
| IAD 1A at baseline → IAD 2A/B | 2 | 1 | 2 |
| IAD 1A at baseline → no IAD | 7 | 5 | 4 |
Erythema measured with the Mexameter MX® 18 (Courage + Khazaka, Cologne, Germany). Means of two duplicate measurements per skin area are displayed in arbitrary units (AU) ranging from 0 (= no erythema) to 999 (= extreme erythema).
| AU | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Day 2 | 258 ± 108.0 | 266 ± 88.2 | 267 ± 96.0 |
| Day 4 | 248 ± 95.8 | 286 ± 107.0 | 254 ± 99.8 |
| Day 6 | 261 ± 115.0 | 288 ± 107.0 | 277 ± 94.9 |
| Day 8 | 267 ± 86.5 | 288 ± 87.9 | 281 ± 97.2 |
| Day 10 | 265 ± 101.0 | 276 ± 91.2 | 255 ± 119.0 |
| Day 12 | 273 ± 103.0 | 278 ± 79.4 | 280 ± 101.0 |
| Day 14 | 288 ± 108.0 | 272 ± 82.8 | 277 ± 99.8 |
Clinical rating of erythema is conducted according to the item 'Redness' of the incontinence-associated dermatitis and its severity (IADS) instrument. The 3-Item-Scale describes 'Redness' as (1) none, (2) pink, (3) red/ bright red.
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Day 6 — Pink | 7 | 6 | 5 |
| Day 6 — Red/Bright Red | 1 | 1 | 0 |
| Day 14 — Pink | 1 | 3 | 1 |
| Day 14 — Red/Bright Red | 2 | 1 | 0 |
The presence (no or yes) of erosion is defined according to the latest International League of Dermatological Societies glossary of cutaneous lesions as a loss of either a portion of or the entire epidermis. Number of subjects developing erosions of all subjects (cumulative incidence).
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Day 6 | 2 | 0 | 0 |
| Day 14 | 0 | 1 | 0 |
The presence (no or yes) of maceration is defined as the result of prolonged exposure (of the skin) to moisture and causes the skin to soften and breakdown so that the connective fibres can be teased apart and the skin often exhibits a white appearance. Number of subjects developing maceration of all subjects (cumulative incidence).
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Day 6 | 3 | 5 | 0 |
| Day 14 | 1 | 2 | 0 |
Numeric Rating Scale (NRS) pain score. The NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity. The NRS was administered only to participants without cognitive impairment (MMSE ≥24).
| scores on a scale | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Day 6 | 0.0 ± 0.0 | — | 0.0 ± 0.0 |
| Day 14 | 0.0 ± 0.0 | 1.5 ± 2.1 | — |
IAD related itch will be reported directly by patients (yes or no). Number of subjects reporting itch of all subjects (cumulative incidence).
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Day 6 | 1 | 0 | 0 |
| Day 14 | 0 | 0 | 0 |
The presence of local intolerances will be assessed with the following options: (0) None; 1. homogeneous redness with scattered papules; 2. homogeneous redness and homogeneous infiltration 3. homogeneous redness and infiltration with vesicles 4. homogeneous redness and infiltration with coalescing vesicles
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Presence of Local Intolerances | 0 | 0 | 0 |
AEs and SAEs will be documented and reported according to the current regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) Article 2.
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | 0 | 0 | 0 |
Incidents abd serious incidents will be documented according to the definition of the EU regulation 2017/745 MDR Article 2 and reported to the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
| Participants | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care |
|---|---|---|---|
| Incidents and Serious Incidents | 0 | 0 | 0 |
Collected over From enrollment until the end of study participation (maximum 14-day follow-up).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ESENTA™ Skin Barrier Spray | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Hydrophobes Basisgel DAC | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Standard Care | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Continuous(years) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| Mean | 82.8 ± 7.5 | 82.0 ± 9.6 | 82.5 ± 8.1 | 82.4 ± 8.4 |
| Sex: Female, Male(Participants) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| Female | 42 | 41 | 38 | 121 |
| Male | 15 | 16 | 15 | 46 |
| Race and Ethnicity Not Collected(Participants) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Body Mass Index (BMI)(kg/m2) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| Mean | 25.2 ± 6.3 | 24.8 ± 5.2 | 24.7 ± 6.3 | 24.9 ± 5.9 |
| Care level(Participants) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| None | 2 | 0 | 2 | 4 |
| Care level 1 | 0 | 1 | 0 | 1 |
| Care level 2 | 2 | 5 | 6 | 13 |
| Care level 3 | 19 | 7 | 9 | 35 |
| Care level 4 | 21 | 25 | 20 | 66 |
| Care level 5 | 10 | 17 | 14 | 41 |
| Unknown | 3 | 2 | 2 | 7 |
| Main Medical Diagnoses(Participants) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| Hypertension | 34 | 32 | 34 | 100 |
| Dementia | 24 | 35 | 26 | 85 |
| Renal failure | 20 | 23 | 17 | 60 |
| Diabetes mellitus | 15 | 13 | 16 | 44 |
| Heart arrhythmia | 17 | 16 | 16 | 49 |
| Diarrhoea(Participants) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| Count of participants | 1 | 3 | 1 | 5 |
| Urinary tract infection(Participants) | ESENTA™ Skin Barrier Spray | Hydrophobes Basisgel DAC | Standard Care | Total |
|---|---|---|---|---|
| Count of participants | 3 | 5 | 1 | 9 |
11 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Study Protocol will be shared as part of this trial registration.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available beginning 12 months and ending 36 months after publication of trial results.
Access criteria: IPD will be shared with researchers who submit a methodologically sound proposal. The proposal must clearly state the research objectives and the intended methods of analysis. It is planned to share the data with restricted access via zenodo.org.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →