Incontinence-associated DermatitisPIDNCT05403762

Prevention of Incontinence-associated Dermatitis

A study testing ESENTA™ Skin Barrier Spray (ConvaTec, UK) and Hydrophobes Basisgel DAC in people with Incontinence-associated Dermatitis, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Incontinence-associated Dermatitis
What is being tested?: ESENTA™ Skin Barrier Spray (ConvaTec, UK) and Hydrophobes Basisgel DAC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteGermany
Study dates: 19 Aug 2022to 6 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Geriatric patients or residents being incontinent of urine and stool
Expected minimum length of stay of 14 days at the care facility
Intact skin with no clinical signs of IAD OR
intact skin with early clinical signs of IAD (IAD category 1A)
Written informed consent

Who cannot join

Residents/patients at the end of life
Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area
Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection)
Known hypersensitivity or allergy to silicones and/or topical leave-on products
Topical treatments in the IAD area.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117

Other trials in Germany

About this study

Official title: Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)

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.

Read the detailed description

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.

Conditions: Incontinence-associated Dermatitis
Being tested: ESENTA™ Skin Barrier Spray (ConvaTec, UK), Hydrophobes Basisgel DAC
Keywords: Skin care, Long-term care, Nursing home resident, Erythema, Geriatric medicine
Medical subject headings: Erythema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ESENTA™ Skin Barrier Spray (ConvaTec, UK)Other
Also called Film-forming skin protectant
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.
Hydrophobes Basisgel DACOther
Also called Hydrophobic 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.

Study groups in NCT05403762
Study group	Role	What they receive
ESENTA™ Skin Barrier Spray	Experimental	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. Receives: Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)
Hydrophobes Basisgel DAC	Experimental	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. Receives: Other: Hydrophobes Basisgel DAC
Standard Care	No intervention	In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 14 Days

Secondary outcomes (9)

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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 20226 Feb 2025

First posted3 Jun 2022
Study start19 Aug 2022
Primary completion6 Feb 2025
Study completion6 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Incontinence-associated DermatitisStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05403762
Sponsor's protocol ID: PID
Other IDs: 01KG2020
Acronym: PID
Status last verified: Feb 2026
First submitted: 23 May 2022
Last updated: 18 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study Protocol will be shared as part of this trial registration.

Publications

El Genedy-Kalyoncu M, Fastner A, Volzer B, Raeder K, Neumann K, Lahmann NA, Kottner J. Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlled pragmatic trial. BMJ Open. 2022 Sep 29;12(9):e065909. doi: 10.1136/bmjopen-2022-065909.
PubMed 36175092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence

All Incontinence-associated Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)
ClinicalTrials.gov ID: NCT05403762
Acronym / sponsor ID: PID / PID
Conditions: Incontinence-associated Dermatitis
Keywords: Skin care, Long-term care, Nursing home resident, Erythema, Geriatric medicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Study start: 19 Aug 2022 (actual)
Primary completion: 6 Feb 2025 (actual)
Study completion: 6 Feb 2025 (actual)
First posted: 3 Jun 2022 (actual)
Results: Posted 18 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ESENTA™ Skin Barrier Spray	Experimental	Other: ESENTA™ Skin Barrier Spray (ConvaTec, UK)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.
Hydrophobes Basisgel DAC	Experimental	Other: Hydrophobes Basisgel DACIn 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.
Standard Care	No intervention	–In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Geriatric patients or residents being incontinent of urine and stool
Expected minimum length of stay of 14 days at the care facility
Intact skin with no clinical signs of IAD OR
intact skin with early clinical signs of IAD (IAD category 1A)
Written informed consent

Key exclusion criteria (5 listed)

Residents/patients at the end of life
Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area
Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection)
Known hypersensitivity or allergy to silicones and/or topical leave-on products
Topical treatments in the IAD area.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ESENTA™ Skin Barrier Spray (ConvaTec, UK)Also: Film-forming skin protectantThe 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.	Other	ESENTA™ Skin Barrier Spray
Hydrophobes Basisgel DACAlso: Hydrophobic skin protectantThe skin protectant will be applied on clean and dry skin. It contains 95% paraffin oil and creates a hydrophobic layer on the skin surface.	Other	Hydrophobes Basisgel DAC

Primary outcome

Incidence of Incontinence-associated Dermatitis (IAD)
Time frame: 14 Days
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

9 secondary outcomes

Erythema (Instrumental Measurement)
Time frame: 14 Days
Erythema (Visual Inspection)
Time frame: 14 Days
Incidence of Erosion
Time frame: 14 Days
Incidence of Maceration
Time frame: 14 Days
IAD Related Pain
Time frame: 14 Days
Incidence of IAD Related Itch
Time frame: 14 Days
Presence of Local Intolerances
Time frame: 14 Days
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 14 Days
Incidents and Serious Incidents
Time frame: 14 Days

Results and safety

Results posted to the registry on 18 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ESENTA™ Skin Barrier Spray	57	57
Hydrophobes Basisgel DAC	57	57
Standard Care	53	53

Primary outcome: Incidence of Incontinence-associated Dermatitis (IAD)

Time frame: 14 Days. Count of participants. Unit: Participants

Measure	ESENTA™ Skin Barrier Spray n = 57	Hydrophobes Basisgel DAC n = 57	Standard Care n = 53
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

Population analysed: Denominators vary because outcome-specific at-risk populations were defined by baseline IAD status. Participants with IAD category 2 at baseline were excluded from the study. Incidence of IAD 2A/2B is based on all enrolled participants (n=167). Incidence of IAD 1 or 2 (n=143) excludes those with IAD 1A at baseline. Other rows are restricted to baseline-defined subgroups (no IAD or IAD 1A).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until the end of study participation (maximum 14-day follow-up).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ESENTA™ Skin Barrier Spray	0 of 57 (0%)	0 of 57 (0%)	0 of 57
Hydrophobes Basisgel DAC	0 of 57 (0%)	0 of 57 (0%)	0 of 57
Standard Care	0 of 53 (0%)	0 of 53 (0%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36175092El Genedy-Kalyoncu M, Fastner A, Volzer B, Raeder K, Neumann K, Lahmann NA, Kottner J. Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlled pragmatic trial. BMJ Open. 2022 Sep 29;12(9):e065909. doi: 10.1136/bmjopen-2022-065909.
Individual participant dataSharing planned: Yes. Study Protocol will be shared as part of this trial registration.

Related trials for Incontinence-associated Dermatitis

Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jan Kottner, Prof. principal investigator

Charite University, Berlin, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Incontinence-associated Dermatitis (IAD) (time frame: 14 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403762, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.