{
  "id": "colloidal-oatmeal",
  "idVersion": 1,
  "ingredient": "Colloidal oatmeal",
  "route": "topical",
  "grade": "strong",
  "gradeLabel": "Strong",
  "claim": "A complete 1% colloidal oatmeal cream was non-inferior to a named prescription barrier cream over three weeks in 90 children with mild-to-moderate atopic dermatitis.",
  "caveat": "The non-inferiority result applies to the tested complete 1% cream and its prescription barrier-cream comparator, not colloidal oatmeal in isolation. The hand-eczema study used fluocinolone for the first two weeks before the oatmeal-versus-base phase. FDA monograph concentrations are regulatory facts, not clinical efficacy thresholds.",
  "published": "2026-09-19",
  "sources": [
    {
      "url": "https://pubmed.ncbi.nlm.nih.gov/28366039/",
      "journal": "J Dermatolog Treat",
      "year": 2017,
      "n": 90,
      "design": "Double-blind randomized active-controlled study",
      "duration": "3 weeks",
      "percentages": [
        "1%"
      ],
      "outcome": "eczema area and severity index, itch, global atopic-dermatitis assessment",
      "finding": "Double-blind randomized active-controlled study in 90 children over three weeks: the complete 1% colloidal oatmeal cream was non-inferior to the prescription barrier cream for EASI, using a prespecified 1.5-point non-inferiority margin.",
      "formulation": "complete 1% colloidal oatmeal cream, ceramide-based prescription barrier cream"
    },
    {
      "url": "https://pubmed.ncbi.nlm.nih.gov/32273745/",
      "journal": "Clin Cosmet Investig Dermatol",
      "year": 2020,
      "n": 50,
      "design": "Double-blind randomized study",
      "duration": "6 weeks",
      "percentages": [],
      "outcome": "hand eczema severity, itch, dermatology life quality index",
      "finding": "Double-blind randomized study with 50 completers: both groups improved during the two-week fluocinolone lead-in; during the following four weeks, the oatmeal arm held improvement while symptoms in the base-cream arm returned toward baseline.",
      "formulation": "fluocinolone 0.025% for two weeks followed by 1% colloidal oatmeal cream, fluocinolone 0.025% for two weeks followed by base cream"
    },
    {
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M016SkinProtectantDrugProductsforOTCHumanUse09242021.pdf",
      "journal": "FDA OTC Monograph M016",
      "year": 2021,
      "n": null,
      "design": null,
      "duration": null,
      "percentages": [
        "0.007%",
        "0.003%"
      ],
      "outcome": "skin-protectant regulatory status",
      "finding": "The US OTC skin-protectant monograph names colloidal oatmeal itself as an active ingredient at a minimum 0.007%, or 0.003% when combined with mineral oil under the specified monograph condition.",
      "formulation": "colloidal oatmeal at 0.007% minimum, colloidal oatmeal at 0.003% minimum with mineral oil"
    }
  ],
  "peopleReport": null
}