N/A
N=100
Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01375205 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months — 13.2; 25 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cetaphil Restoraderm (Other); Standard of Care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months |
13.2; 25 | — |
| SECONDARY Percentage of High Emollient Use |
87; 45.2; 72.4; 45.8; 66.7; 45.5 | — |
| SECONDARY Age at Onset of Eczema |
4; 6 | — |
| SECONDARY Filaggrin Mutation Status |
3; 2; 22; 29 | — |
| SECONDARY Transepidermal Water Loss (TEWL) |
16.3; 18.3; 15.9; 16.1; 13.9; 16.7 | — |
| SECONDARY Skin Hydration (Skin Electrical Capacitance) |
55.2; 53.9; 51.8; 52.1; 49.4; 53.7 | — |
| SECONDARY Skin pH |
5.5; 5.2; 5.3; 5.4; 5.4; 5.4 | — |
Summary
The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson & Johnson baby lotion and skin cleanser.
Eligibility Criteria
Inclusion Criteria
- Infants up to three weeks of age born to mothers aged 18-45 years will be recruited for this study.
- Infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health.
Exclusion Criteria
- Preterm birth defined as birth prior to 37 weeks gestation
- Major congenital anomaly
- Hydrops fetalis
- Significant dermatitis at birth not including seborrheic dermatitis on the scalp ("cradle cap")
- Any immunodeficiency disorder
- Any severe genetic skin disorder
- Any other serious condition that would make the use of emollients inadvisable
- Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess
Data sourced from ClinicalTrials.gov (NCT01375205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.