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Investigating the use of a skin barrier protectant for patients with incontinence-associated dermatitis (IAD)

Investigating the effect of a skin barrier protectant for patients with incontinence-associated dermatitis (IAD) in a randomized, parallel-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240923063136N5
Enrollment
20
Registered
2025-05-04
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence-associated dermatitis. Irritant contact dermatitis due to fecal, urinary or dual incontinence

Interventions

Intervention 1: Intervention group: Patients receive an acrylate skin protectant. This protectant is made of cyanoacrylate and contains thymoquinone (bioactive compound of Nigella sativa). The duratio

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with incontinence have either urine or feces, or both.

Exclusion criteria

Exclusion criteria: IAD is limited to those with erythema only, and those with erosions or denudation of the skin are excluded from the study. People with bacterial/fungal infections were excluded from the study. Patients with known allergies to the therapeutic products considered in this study (i.e., zinc oxide or cyanoacrylate) or who showed sensitivity during the intervention period were excluded from the study. Unable to tolerate products for skin cleansing. Those who have ostomy. Having skin problems in the gluteal region, genitals or thighs.

Design outcomes

Primary

MeasureTime frame
Skin redness (erythema). Timepoint: On day 0 (before intervention) and day 21 (after end of intervention). Method of measurement: Clinician's Erythema Assessment (CEA) scale. (It has grades 0 to 4).

Secondary

MeasureTime frame
Itching/burning at affected skin area. Timepoint: On day 0 (before intervention) and day 21 (after end of intervention). Method of measurement: Numerical rating scale (NRS).;Pain at affected skin area. Timepoint: On day 0 (before intervention) and day 21 (after end of intervention). Method of measurement: Numerical rating scale (NRS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactCyrus Jalili

Kermanshah University of Medical Sciences

cjalili@kums.ac.ir+98 83 3835 8943

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026