Treatment of Incontinence Associated Dermatitis in Older Children and Adults

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of the Philippines
• Collaborator: Calmoseptine, Inc.
• Treatments: Menthol; Zinc Oxide

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discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study.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.