Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
Condition: Diaper Dermatitis
MeSH terms: Dermatitis; Diaper Rash
Study type: Interventional
Phase: Phase 4

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 Each participant has one week total participation, unless withdrawn.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

Intervention name(s): Calmoseptine Ointment; Destin Maximum Strength 40% Zinc
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Other intervention name(s): Calmoseptine; Destin
Intervention MeSH terms: Menthol; Petrolatum; Zinc Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonates; infants