Evidence recordApplied to skin
Colloidal oatmeal
Answer
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.
Check the formulaEvidence grade
Strong
Several consistent, relevant sources or an authoritative synthesis support this bounded claim.
Where it stops
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.
Sources
Sources · 3
Source 1
J Dermatolog Treat, 2017- Design
- Double-blind randomized active-controlled study
- Participants
- 90
- Duration
- 3 weeks
- Reported numbers
- 1%
- Measured outcome
- eczema area and severity index, itch, global atopic-dermatitis assessment
- Studied formulation
- complete 1% colloidal oatmeal cream, ceramide-based prescription barrier cream
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.
- Design
- Double-blind randomized study
- Participants
- 50
- Duration
- 6 weeks
- Measured outcome
- hand eczema severity, itch, dermatology life quality index
- Studied formulation
- fluocinolone 0.025% for two weeks followed by 1% colloidal oatmeal cream, fluocinolone 0.025% for two weeks followed by base cream
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.
Source 3
FDA OTC Monograph M016, 2021- Reported numbers
- 0.007%, 0.003%
- Measured outcome
- skin-protectant regulatory status
- Studied formulation
- colloidal oatmeal at 0.007% minimum, colloidal oatmeal at 0.003% minimum with mineral oil
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.