Clinical trial NCT02716415: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diaper Dermatitis
Keywords: neonates
infants
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Calmoseptine, Inc.
First posted: 2016-03-23
Enrollment: 319
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Each participant has one week total participation, unless withdrawn.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.

Eligibility criteria: 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)

Primary outcomes:
measure: Healing of diaper Dermatitis
timeFrame: Assessed on Final day of data collection (Day 6)
Secondary outcomes:
measure: Daily Diaper Dermatitis Severity Score
timeFrame: Assessed on Day 0, 1, 2, 3, 4, 5, and 6
Other outcomes:
measure: Size of area affected by diaper dermatitis on Days 0-6.
timeFrame: Measured on Day 0, 1, 2, 3, 4, 5, and 6
measure: Adverse Events.
timeFrame: Recorder on Day 0, 1, 2, 3, 4, 5, and 6
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital - University of the Philippines, Manila
state: Metro Manila
Study officials:
affiliation: Department of Pediatrics, Philippine General Hospital UP Manila
name: Jacinto Blas Mantaring, MD
role: PRINCIPAL_INVESTIGATOR
References: