Incontinence Associated DermatitisPhase 3NCT02080247
Treatment of Incontinence Associated Dermatitis in Older Children and Adults
A Phase 3 study testing Skin care regimen with Calmoseptine ointment and Skin care regimen with Destin ointment in people with Incontinence Associated Dermatitis, run by University of the Philippines at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Incontinence Associated Dermatitis
- What is being tested?
- Skin care regimen with Calmoseptine ointment and Skin care regimen with Destin ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 sitePhilippines
- Study dates
- Dec 2012to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study.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.
Who cannot join
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital - University of the Philippines Manila
Manila, National Capital Region, 1000
About this study
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
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.
Read the 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
- Being tested
- Skin care regimen with Calmoseptine ointment, Skin care regimen with Destin ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin care regimen with Calmoseptine ointmentDrug
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).
Skin care regimen with Destin ointmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Skin care regimen with Destin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days up to complete healing of the Incontinence Associated Dermatitis
Secondary outcomes (1)
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.
Measured: 6 days up to complete healing of the Incontinence Associated Dermatitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incontinence Associated DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Calmoseptine, Inc.
- Responsible party
- Sponsor
- Investigators
- Rodney B. Dofitas, Medical Doctor, Principal investigator, University of the Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080247
- Sponsor's protocol ID
- UPMREB-2012-051-CT-PGH
- Status last verified
- Apr 2014
- First submitted
- 4 Mar 2014
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40643063
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02080247
- Acronym / sponsor ID
- UPMREB-2012-051-CT-PGH
- Conditions
- Incontinence Associated Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Calmoseptine, Inc.
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Skin care regimen with Calmoseptine ointment | Active comparator | Drug: Skin care regimen with Calmoseptine ointmentIn this arm the patients with IAD will receive treatment with Calmoseptine Ointment for 6 days as a part of a structured skin regimen |
| Control: Skin care regimen with Destin ointment | Active comparator | Drug: Skin care regimen with Destin ointmentIn 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
- Participant has a diagnosis of IAD with a severity score less than 3 as determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin care regimen with Calmoseptine ointmentApplication 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). | Drug | Intervention: Skin care regimen with Calmoseptine ointment |
| Skin care regimen with Destin ointmentApplication 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. | Drug | Control: Skin care regimen with Destin ointment |
Primary outcome
Complete healing of Incontinence Associated Dermatitis
Time frame: 6 days up to complete healing of the 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.
1 secondary outcome
Pain scale measured by Wong Baker
Time frame: 6 days up to complete healing of the Incontinence Associated Dermatitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Derived from this study: PubMed 40643063Graham 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.
Related trials for Incontinence Associated Dermatitis
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney B. Dofitas, Medical Doctor principal investigator
University of the Philippines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Skin care regimen with Calmoseptine ointment and Skin care regimen with Destin ointment in people with Incontinence Associated Dermatitis, run by University of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete healing of Incontinence Associated Dermatitis (time frame: 6 days up to complete healing of the Incontinence Associated Dermatitis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.