Treatment of Incontinence Associated Dermatitis in Older Children and Adults

NCT ID: NCT02080247

Last Updated: 2014-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Skin care regimen with Calmoseptine ointment

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

Group Type: ACTIVE_COMPARATOR

Skin care regimen with Calmoseptine ointment

Intervention Type: 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).

Control: Skin care regimen with Destin ointment

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.

Group Type: ACTIVE_COMPARATOR

Skin care regimen with Destin ointment

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Calmoseptine, Inc.

INDUSTRY

Sponsor Role: collaborator

University of the Philippines

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodney B. Dofitas, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines

Locations

Philippine General Hospital - University of the Philippines Manila

Manila, National Capital Region, Philippines

Countries

Philippines

References

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.

Reference Type: DERIVED

PMID: 40643063 (View on PubMed)

Other Identifiers

UPMREB-2012-051-CT-PGH

Identifier Type: -

Identifier Source: org_study_id