Treatment of Incontinence Associated Dermatitis in Older Children and Adults

Incontinence Associated Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080247
• Other study ID #: UPMREB-2012-051-CT-PGH
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2014
• Last updated: April 10, 2014
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ethics Board University of the Philippines Manila - Office of the Vice Chancellor for Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Participant or next of kin/parent/guardian agree to study inclusion and sign the informed consent form or the assent form according to detailed guidance in the consent / assent section.

• Ages: children (at least 12 years old and up to 18 years old ) and adults (18 years old and above)

• Participant is incontinent* of urine and/or feces and has concomitant Incontinent Associated Dermatitis (IAD). (*Including functional incontinence, whereby the ability to control micturition or defecation is intact, but the patient is unable to toilet normally due to immobilization or other reason.).

• There is a reasonable expectation that the participant will be hospitalized for at least 7 days and will be able to complete the study. (NB Study Participant Withdrawal Criteria b - Any participants discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study. Study participation will not under any circumstances lead to delay in a participant's discharge from hospital.).

• Participant has no known allergy or history of adverse reaction to any of the ingredients in either product or to any topical preparations or skin care products.

• Participant has a diagnosis of IAD with a severity score greater than or equal to 3 as determined by the investigator.

Exclusion Criteria:

• Participant has a pre-existing pressure ulcer of stage 3 or 4 or other full thickness wound within the study area

• Participant has an active dermatological condition, or a history of recurrent dermatological conditions, other than IAD, that may affect healing of IAD or imply difficult healing of IAD. Where uncertainty exists, the Investigators will arrange a consultation with a Consultant Dermatologist

• Participant has any severe acute or chronic medical condition such that trial participation may constitute a risk or may interfere with their medical care or their attending physician advises against participation.

• Participant has in the preceding week been treated with systemic or topical agents (other than topical treatments for IAD) that may affect the IAD healing process (for example steroids).

e. Participant has a known allergy or previous adverse reactions to any of the ingredients in either product.

• Participant has a diagnosis of IAD with a severity score less than 3 as determined by the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Incontinence Associated Dermatitis

Intervention

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).
• 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.

Locations

Country	Name	City	State
Philippines	Philippine General Hospital - University of the Philippines Manila	Manila	Metro Manila

Sponsors (2)

Lead Sponsor	Collaborator
University of the Philippines	Calmoseptine, Inc.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing of Incontinence Associated Dermatitis	The Primary outcome is complete healing of IAD. Complete healing will be defined with the Kennedy IAD Severity Score. It is a cumulative severity score ranging from zero (no IAD) to 9 (an area > 50 cm² affected, redness or inflammation that is uniformly severe in appearance, extreme erosion of the epidermis and dermis with moderate volume and persistent exudate). The score is generated by the IAD Skin Condition Assessment Tool developed by Kennedy and Lutz, which requires assessors to attribute scores of 0-3 for three domains: size of area affected, skin redness or inflammation, and erosion. The sum of these scores is the IAD Severity Score. The size of IAD affected area 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). Disposable paper tape measures should be used to prevent cross-infection.	6 days up to complete healing of the Incontinence Associated Dermatitis	Yes
Secondary	Pain scale measured by Wong Baker	IAD associated pain will be assessed using Wong Baker pain scale. The Wong Baker scale is the most appropriate pain scale for children or adults with cognitive impairment and VAS for older minors and adults. Wong baker pain scale is a simple visual instrument originally designed for assessing pain in children, but has been used in adult populations.	6 days up to complete healing of the Incontinence Associated Dermatitis	Yes