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Search / Trial NCT02716415

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

Launched by UNIVERSITY OF THE PHILIPPINES · Mar 22, 2016

Trial Information

Current as of July 21, 2025

Completed

Keywords

Neonates Infants

ClinConnect Summary

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 Each participant has one week total participation, unless withdrawn.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

Gender

ALL

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discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study.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

About University Of The Philippines

The University of the Philippines, a premier academic institution and research hub, is dedicated to advancing healthcare through innovative clinical trials. With a strong emphasis on ethical research practices and community engagement, the university leverages its extensive resources and expertise to conduct rigorous studies that contribute to the understanding and treatment of various medical conditions. As a sponsor of clinical trials, the University of the Philippines fosters collaborations with healthcare professionals, researchers, and stakeholders to ensure the highest standards of scientific integrity and patient safety, ultimately aiming to improve health outcomes and inform public health policy.

Locations

Manila, Metro Manila, Philippines

Patients applied

0 patients applied

Trial Officials

Jacinto Blas Mantaring, MD

Principal Investigator

Department of Pediatrics, Philippine General Hospital UP Manila

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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