Back to resultsTreatment of Incontinence Associated Dermatitis in Older Children and Adults
Primary Purpose
Incontinence Associated Dermatitis
Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Skin care regimen with Calmoseptine ointment
Skin care regimen with Destin ointment
Sponsored by
About this trial
This is an interventional treatment trial for Incontinence Associated Dermatitis
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discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study.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.
Sites / Locations
- Philippine General Hospital - University of the Philippines Manila
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention: Skin care regimen with Calmoseptine ointment
Control: Skin care regimen with Destin ointment
Arm Description
In this arm the patients with IAD will receive treatment with Calmoseptine Ointment for 6 days as a part of a structured skin regimen
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02080247
First Posted
March 4, 2014
Last Updated
April 10, 2014
Sponsor
University of the Philippines
Collaborators
Calmoseptine, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02080247
Brief Title
Treatment of Incontinence Associated Dermatitis in Older Children and Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Philippines
Collaborators
Calmoseptine, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence Associated Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Skin care regimen with Calmoseptine ointment
Arm Type
Active Comparator
Arm Description
In this arm the patients with IAD will receive treatment with Calmoseptine Ointment for 6 days as a part of a structured skin regimen
Arm Title
Control: Skin care regimen with Destin ointment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Skin care regimen with Calmoseptine ointment
Intervention Description
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
Intervention Name(s)
Skin care regimen with Destin ointment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete healing of Incontinence Associated Dermatitis
Description
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.
Time Frame
6 days up to complete healing of the Incontinence Associated Dermatitis
Secondary Outcome Measure Information:
Title
Pain scale measured by Wong Baker
Description
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.
Time Frame
6 days up to complete healing of the Incontinence Associated Dermatitis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney B. Dofitas, Medical Doctor
Organizational Affiliation
University of the Philippines
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philippine General Hospital - University of the Philippines Manila
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Treatment of Incontinence Associated Dermatitis in Older Children and Adults
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