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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02716415
• Date of registration: 24/02/2016
• Prospective Registration: No
• Primary sponsor: University of the Philippines
• Public title: Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 319
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02716415
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Philippines

Contacts

• Name: Jacinto Blas Mantaring, MD
• Affiliation: Department of Pediatrics, Philippine General Hospital UP Manila

Key inclusion & exclusion 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before completion of study participation will automatically be withdrawn from the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)



Age minimum: N/A
Age maximum: 12 Months
Gender: All

Health Condition(s) or Problem(s) studied

Diaper Dermatitis

Intervention(s)

Drug: Calmoseptine Ointment

Drug: Destin Maximum Strength 40% Zinc

Primary Outcome(s)

Healing of diaper Dermatitis [Time Frame: Assessed on Final day of data collection (Day 6)]

Secondary Outcome(s)

Daily Diaper Dermatitis Severity Score [Time Frame: Assessed on Day 0, 1, 2, 3, 4, 5, and 6]

Secondary ID(s)

2015-019-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Calmoseptine, Inc.