Clinical trial NCT02080247: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Incontinence Associated Dermatitis
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Calmoseptine, Inc.
First posted: 2014-03-06
Enrollment: 142
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete healing of Incontinence Associated Dermatitis
timeFrame: 6 days up to complete healing of the Incontinence Associated Dermatitis
Secondary outcomes:
measure: Pain scale measured by Wong Baker
timeFrame: 6 days up to complete healing of the Incontinence Associated Dermatitis
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital - University of the Philippines Manila
state: Metro Manila
Study officials:
affiliation: University of the Philippines
name: Rodney B. Dofitas, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: