Treatment of Incontinence Associated Dermatitis in Older Children and Adults

NCT02080247 | Completed Phase 3 DMC

• 1 other identifier: UPMREB-2012-051-CT-PGH
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incontinence Associated Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pain scale measured by Wong Baker

  6 days up to complete healing of the Incontinence Associated Dermatitis

Study Arms (2)

Intervention: Skin care regimen with Calmoseptine ointment

ACTIVE COMPARATOR

In this arm the patients with IAD will receive treatment with Calmoseptine Ointment for 6 days as a part of a structured skin regimen

Drug: Skin care regimen with Calmoseptine ointment

Control: Skin care regimen with Destin ointment

ACTIVE COMPARATOR

In this arm , patient 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.

Drug: Skin care regimen with Destin ointment

Interventions

Skin care regimen with Calmoseptine ointment DRUG

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).

Intervention: Skin care regimen with Calmoseptine ointment

Skin care regimen with Destin ointment DRUG

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.

Control: Skin care regimen with Destin ointment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Philippines: lead
• Calmoseptine, Inc.: collaborator

Study Sites (1)

Philippine General Hospital - University of the Philippines Manila

Manila, National Capital Region, 1000, Philippines

Location

Related Publications (1)

• Graham T, Beeckman D, Kottner J, Fader M, Fiorentino F, Fitzpatrick JM, Gray M, Harris RG, Sooriah S, Wallace SA, Worsley PR, Woodward S. Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2025 Jul 11;7(7):CD011627. doi: 10.1002/14651858.CD011627.pub3.

  PMID: 40643063 DERIVED

Study Officials

• Rodney B. Dofitas, Medical Doctor

  University of the Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: December 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 11, 2014

Record last verified: 2014-04

Locations

PH (1)