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Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants

Primary Purpose

Diaper Dermatitis

Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Calmoseptine Ointment
Destin Maximum Strength 40% Zinc
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaper Dermatitis focused on measuring neonates, infants

Eligibility Criteria

1 Day - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The child participant must be < 1 year of age.
  2. The participant must, upon clinical inspection by an investigator, be assessed to have diaper dermatitis ≥ Grade 2 according to the study's diaper dermatitis severity scale (see "Primary Outcome").
  3. The participant's parent, next of kin or legally acceptable representative agrees to the child's inclusion and signs the informed consent.
  4. The participant's primary physician agrees to inclusion.
  5. 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discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study.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.)
  6. 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

Exclusion Criteria:

  1. Participants with a pre-existing full thickness wound within the study area.
  2. Participants with pre-existing active dermatological condition(s), other than DD, which may affect healing or interpretation of trial results. Where uncertainty exists, the Investigators will arrange a consultation with a Consultant Dermatologist.
  3. Participant has a history of recurrent dermatological conditions, other than DD, that may imply difficult healing or affect interpretation of trial results.
  4. 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 affect interpretation of results, or their attending physician advises against participation.
  5. Participant is on systemic antifungal treatment (eg. Amphotericin B or Fluconazole), topical antifungal treatment and / or systemic or topical corticosteroids.
  6. Participant has in the preceding week been treated with topical agents that may affect healing (e.g. dimethicone based ointments, zinc oxide powder, petroleum jelly)

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

Calmoseptine Ointment

Destin Maximum Strength 40% Zinc

Arm Description

Calmoseptine Ointment as part of a structured skin care regimen.

Destin Maximum Strength 40% Zinc as part of a structured skin care regimen.

Outcomes

Primary Outcome Measures

Healing of diaper Dermatitis
Complete healing of Diaper Dermatitis on final study day, as determined by Diaper Dermatitis Severity Scale. Possible score range from zero (0 - clear skin) ti six (6 - severe erythema, all or most of the diaper area affected, with papules and/or pustules, and open skin affecting the dermis). Complete healing is defined as a Diaper Dermatitis Severity Score of zero (0). Assessment of the primary outcome used in final analyses will be blinded. For determination of final trial results for the primary outcome, sets of high definition photographs for each patient on each treatment day will be assessed by independent wound, Ostomy and Continence Nursing Certification Board (WOCNB) certified wound care expert assessors based in the USA, who are blinded to treatment allocation, not involved in the study.

Secondary Outcome Measures

Daily Diaper Dermatitis Severity Score
Diaper dermatitis severity, assessed as per primary outcome. The size of area affected by diaper dermatitis is measured and recorded at baseline (study entry on Day 0) and on each follow up day (Days 1-6). Disposable paper tape measures are used to prevent cross-infection. Where more than one non-contiguous area is affected, each will be measured as described and added together. As the study will include neonates and infants up to one year of age, body size will differ significantly so that an affected area of a similar size may be more serious in one participant than in another. Accordingly, the mean body size and/or weight of treatment groups will be considered and the expression of area affected used in final analyses will be adjusted appropriately.

Full Information

First Posted
February 24, 2016
Last Updated
April 21, 2020
Sponsor
University of the Philippines
Collaborators
Calmoseptine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02716415
Brief Title
Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
Official Title
Randomized Controlled Trial Comparing the Efficacy and Safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (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
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.
Detailed Description
This is a single-center, randomized, controlled, assessor-blinded clinical trial. Neonates born in UP-PGH or infants (< 1 year of age) in the general pediatric wards for any condition who have diaper dermatitis are recruited and randomized to treatment with either Calmoseptine Ointment or Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste as part of a structured skin care regimen. Each participant has one week total participation, unless withdrawn. Baseline data are collected and study treatment initiated on study entry day. Treatment continued and follow up data collected on six subsequent follow up days. Primary outcome: healing of Diaper Dermatitis after six days of treatment, defined as a Diaper Dermatitis Severity Score of zero attributed by blinded assessment. Secondary outcomes: Diaper Dermatitis Severity Score at each day of treatment; size of affected area; incidence of Candida infection; adverse events. Zinc Oxide Ointment preparations including Calmoseptine Ointment and Desitin Maximum Strength 40% Diaper Rash Paste have been used to treat diaper dermatitis for many years around the world. There are no known reported hypersensitivities to either product and no reported serious adverse events. As the proposed study is in neonates and infants, as a precaution the evidence relating to the safety and toxicity of individual ingredients were reviewed for the trial protocol prior to commencement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaper Dermatitis
Keywords
neonates, infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calmoseptine Ointment
Arm Type
Active Comparator
Arm Description
Calmoseptine Ointment as part of a structured skin care regimen.
Arm Title
Destin Maximum Strength 40% Zinc
Arm Type
Active Comparator
Arm Description
Destin Maximum Strength 40% Zinc as part of a structured skin care regimen.
Intervention Type
Drug
Intervention Name(s)
Calmoseptine Ointment
Other Intervention Name(s)
Calmoseptine
Intervention Description
A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered. The regimen includes: regular diaper changing, gentle cleansing application of the trial ointment
Intervention Type
Drug
Intervention Name(s)
Destin Maximum Strength 40% Zinc
Other Intervention Name(s)
Destin
Intervention Description
A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered. The regimen includes: regular diaper changing, gentle cleansing application of the trial ointment
Primary Outcome Measure Information:
Title
Healing of diaper Dermatitis
Description
Complete healing of Diaper Dermatitis on final study day, as determined by Diaper Dermatitis Severity Scale. Possible score range from zero (0 - clear skin) ti six (6 - severe erythema, all or most of the diaper area affected, with papules and/or pustules, and open skin affecting the dermis). Complete healing is defined as a Diaper Dermatitis Severity Score of zero (0). Assessment of the primary outcome used in final analyses will be blinded. For determination of final trial results for the primary outcome, sets of high definition photographs for each patient on each treatment day will be assessed by independent wound, Ostomy and Continence Nursing Certification Board (WOCNB) certified wound care expert assessors based in the USA, who are blinded to treatment allocation, not involved in the study.
Time Frame
Assessed on Final day of data collection (Day 6)
Secondary Outcome Measure Information:
Title
Daily Diaper Dermatitis Severity Score
Description
Diaper dermatitis severity, assessed as per primary outcome. The size of area affected by diaper dermatitis is measured and recorded at baseline (study entry on Day 0) and on each follow up day (Days 1-6). Disposable paper tape measures are used to prevent cross-infection. Where more than one non-contiguous area is affected, each will be measured as described and added together. As the study will include neonates and infants up to one year of age, body size will differ significantly so that an affected area of a similar size may be more serious in one participant than in another. Accordingly, the mean body size and/or weight of treatment groups will be considered and the expression of area affected used in final analyses will be adjusted appropriately.
Time Frame
Assessed on Day 0, 1, 2, 3, 4, 5, and 6
Other Pre-specified Outcome Measures:
Title
Size of area affected by diaper dermatitis on Days 0-6.
Description
The 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).
Time Frame
Measured on Day 0, 1, 2, 3, 4, 5, and 6
Title
Adverse Events.
Description
Non-Serious and serious adverse events judged by physicians to be due to trial participation.
Time Frame
Recorder on Day 0, 1, 2, 3, 4, 5, and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The child participant must be < 1 year of age. The participant must, upon clinical inspection by an investigator, be assessed to have diaper dermatitis ≥ Grade 2 according to the study's diaper dermatitis severity scale (see "Primary Outcome"). The participant's parent, next of kin or legally acceptable representative agrees to the child's inclusion and signs the informed consent. The participant's primary physician agrees to inclusion. 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 Exclusion Criteria: Participants with a pre-existing full thickness wound within the study area. Participants with pre-existing active dermatological condition(s), other than DD, which may affect healing or interpretation of trial results. Where uncertainty exists, the Investigators will arrange a consultation with a Consultant Dermatologist. Participant has a history of recurrent dermatological conditions, other than DD, that may imply difficult healing or affect interpretation of trial results. 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 affect interpretation of results, or their attending physician advises against participation. Participant is on systemic antifungal treatment (eg. Amphotericin B or Fluconazole), topical antifungal treatment and / or systemic or topical corticosteroids. Participant has in the preceding week been treated with topical agents that may affect healing (e.g. dimethicone based ointments, zinc oxide powder, petroleum jelly)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacinto Blas Mantaring, MD
Organizational Affiliation
Department of Pediatrics, Philippine General Hospital UP Manila
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

Plan to Share IPD
No

Learn more about this trial

Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants

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