NCT02080247

Treatment of Incontinence Associated Dermatitis in Older Children and Adults

A Randomized Controlled Clinical Study Comparing the Efficacy and Safety of Calmoseptine vs Destin Maximum Strength Diaper Rash Paste in Treatment of Incontinence Associated Dermatitis in Older Children and Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: University of the Philippines · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial that compared the use of two topical zinc oxide based diaper rash products in a structured care regimen for the treatment of IAD in hospitalized adults and older children.

Detailed description

Patients with IAD were recruited at Philippine General hospital to participate in a randomized controlled trial of two topical zinc oxide based diaper rash products used as part of a structured care regimen. All patients recruited to either arm of the trial received a structured care regimen for treatment of IAD for six days following study entry. At least twice daily and as required by incontinence episodes, treatment and care was provided by nurses and nursing aids trained in the study regimen to ensure its consistent implementation. Wet or soiled diapers were removed and the affected area was gently cleansed. Vigorous cleaning was avoided. A thin layer of the study topical ointment was applied prior to putting on a new diaper. Packs containing all the materials required were prepared for each patient daily, including the same brand of diapers for all patients, skin cleansing products and materials, and the assigned study ointment. Data were collected each day relating to their IAD using the Kennedy Skin Condition Assessment Scale.

Conditions

• Incontinence Associated Dermatitis

Interventions

Type	Name	Description
DRUG	Skin care regimen with Calmoseptine ointment	Application of Calmoseptine Ointment for 6 days will be applied on the affected area that will be calculated by multiplying the longest portion of the affected area measured in a head to toe orientation by the widest portion of the affected area measured from side to side(in Centimeters).
DRUG	Skin care regimen with Destin ointment	Application of Destin for 6 days will be applied on the affected area that will be calculated by multiplying the longest portion of the affected area measured in a head to toe orientation by the widest portion of the affected area measured from side to side(in Centimeters). Patients will receive treatment with Destin Maximum Strength 40% Zinc Oxide Diaper Rash Paste (Destin) for 6 days as part of a structured skin care regimen.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-03-06
• Last updated: 2014-04-11

Locations

1 site across 1 country: Philippines