The Healthy Baby Bottoms Study
Condition: Diaper Dermatitis
MeSH terms: Dermatitis; Diaper Rash
Intervention: Diaper care with Theraworx
Intervention description: Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes
Intervention MeSH terms: Zinc Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Diaper dermatitis is one of the most common dermatologic diseases affecting infants and
      children. The incidence is highest among those 9-12 months old and it has been reported to
      affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several
      factors including: excessive moisture, topical irritants, reduced pH, friction, maceration
      and bacterial infection. When infants soil their diaper, diaper contents saturate the area
      raising the pH of the skin above the normal level of 5 or less, and leaving the area highly
      vulnerable to maceration from friction. Irritants in urine and feces are then able to
      penetrate the macerated skin, causing inflammation and greater skin friability. An elevation
      in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the
      skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam
      Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for
      temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such,
      Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper
      rash wounds, as well as for assisting with wound healing and reducing any associated pain.
      The purpose of this study is to determine caregivers' perceptions of the benefits of using
      Theraworx Foam on their infant's diaper area as part of their hygienic routine, including
      whether they feel the product is pleasant and easy to use, and whether they feel it helps
      prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Read English at the 8th grade level

          -  Have reliable access to email for 7 weeks

          -  Complete the first online survey within 24 hours of the request

          -  Custodial guardian of an infant between the ages of 1-12 months old living with
             him/her, wearing diapers, and has had ≥1 diaper rash in the 2 months preceding
             recruitment

        Exclusion Criteria:

          -  Does not have a stable address at which to receive a package of Theraworx and is
             unable/unwilling to pick it up at Children's National Health System

          -  Infant is immunocompromised, has a congenital disorder, or on the day of recruitment,
             has a diaper rash, has a moderate to severe illness requiring hospitalization or
             transfer to the emergency room, or was circumcised <10 days prior.