Trial · NCT03409367
A Community-based Assessment of Skin Care, Allergies, and Eczema
NCT03409367, Not applicable, Completed, Oregon Health and Science University; results first posted 2025-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Community-based Assessment of Skin Care, Allergies, and Eczema. Trials, record NCT03409367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03409367
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Community-based Assessment of Skin Care, Allergies, and Eczema
- NCT number
- NCT03409367
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,260 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Atopic Dermatitis, Atopic Disorders, Eczema, Atopic Eczema
- Interventions
- Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream
- First posted
- 2018-01-24
- Last updated
- 2025-08-15
- Results first posted
- 2025-08-15
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Provider-diagnosed Atopic Dermatitis | up to 24 months | The cumulative incidence of AD as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record. |
| Secondary | Parent Report of Atopic Dermatitis | up to 24 months | Parent or guardian reports that a clinician has diagnosed their child with atopic dermatitis (eczema) at any quarterly contact up to 24 months of age. |
| Secondary | Atopic Dermatitis by UK Working Party Criteria | up to 24 months | Parental report of AD using UK Working Party criteria. Parent responds "yes" to all parts of a modified version of the UK Working Party criteria at 12 and/or 24 month. Criteria include an itchy rash in flexural areas, generally dry skin, and asthma or hay fever in a first-degree relative. |
| Secondary | Atopic Dermatitis by Children's Eczema Questionnaire | up to 24 months | AD as diagnosed by the Children's Eczema Questionnaire (CEQ). Parent response to 3 CEQ questions is consistent with AD at 12 and/or 24 months of age. |
| Secondary | Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart | up to 24 months | Cumulative incidence of provider-diagnosed AD requiring prescription or over-the-counter therapies from chart review. Health records at primary care practice includes both a diagnosis of AD and prescription and/or over-the-counter (OTC) therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines. |
| Secondary | Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) | Up to 24 months | Ordinal coding of diagnosis of atopic dermatitis (eczema) in primary care health records, coded as none, eczema without prescription or over-the-counter (OTC) topical therapies, eczema with OTC only, or eczema with prescription therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines. |
| Secondary | Prescribed or Over-the-counter Topical Skin Medication by Parent Report | up to 24 months | Ordinal formulation of parent report: no AD, AD not treated with steroidal or non-steroidal cream or ointment ("therapy"), AD treated with over-the-counter (OTC) therapy, AD treated with prescription therapy. AD could be reported on annual questionnaires or quarterly contacts. Therapies reported on annual questionnaires. |
| Secondary | Skin Infections Diagnosed and Recorded in Chart Review | up to 24 months | Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics. Skin infection diagnoses include impetigo, candida, wart/verruca, molluscum, or herpes simplex. |
| Secondary | Provider-diagnosed Asthma | up to 24 months | Health records at primary care practice include at least one diagnosis of asthma. |
| Secondary | Severity of AD Symptoms Using POEM | 12 months of age | Patient-Oriented Eczema Measure (POEM) score, elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The POEM has seven items and ranges from 0 to 28, with higher scores reflecting more severe symptoms of AD. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Provider-diagnosed Atopic Dermatitis | up to 24 months | Diagnosis of atopic dermatitis recorded by primary care clinicians in health records by 24 (+/- 3) months of age. Multiple imputation of 199 missing outcomes (92 intervention, 107 control). All ITT with multiple imputation for participants with absent outcome data. Numbers represent participants per randomized arm, regardless of adherence to instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Parent Report of Atopic Dermatitis | up to 24 months | Multiple imputation of 111 outcomes considered missing when parent did not respond at 21 or 24 months and no diagnosis had been reported at earlier contacts. All ITT with multiple imputation for 9% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis by UK Working Party Criteria | up to 24 months | Multiple imputation of 148 outcomes considered missing when parent did not respond at 24 months and the previous 12-month contact was not positive for AD by these criteria. All ITT with multiple imputation for 12% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis by Children's Eczema Questionnaire | up to 24 months | Multiple imputation of 136 outcomes considered missing when parent did not respond at 24 months and the previous 12-month contact was not positive for AD by these criteria. All ITT with multiple imputation for 11% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart | up to 24 months | Multiple imputation of 199 missing outcomes. All ITT with multiple imputation for 16% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) | Up to 24 months | All ITT with multiple imputation for 16% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Prescribed or Over-the-counter Topical Skin Medication by Parent Report | up to 24 months | Participants with (a) a parent report of provider diagnosis from an annual questionnaire or quarterly contact or (b) if no diagnosis, a parent response to a quarterly or annual contact at 21 to 24 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | participants | NUMBER |
| SECONDARY | Skin Infections Diagnosed and Recorded in Chart Review | up to 24 months | All participants with (a) at least one primary care visit between 20 and 27 months of age or (b) a skin infection diagnosis earlier than 20 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Provider-diagnosed Asthma | up to 24 months | All participants with (a) at least one primary care visit between 20 and 27 months of age or (b) asthma diagnosis earlier than 20 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | participants | NUMBER |
| SECONDARY | Severity of AD Symptoms Using POEM | 12 months of age | Respondents to 12-month questionnaires who reported a provider diagnosis of AD in the same questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | score on a scale | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Provider-diagnosed Atopic Dermatitis | Daily Emollient | 217.7 | Participants with imputed values | ||
| Provider-diagnosed Atopic Dermatitis | Natural Skin | 268.5 | Participants with imputed values | ||
| Parent Report of Atopic Dermatitis | Daily Emollient | 161.1 | Participants with imputed values | ||
| Parent Report of Atopic Dermatitis | Natural Skin | 219.1 | Participants with imputed values | ||
| Atopic Dermatitis by UK Working Party Criteria | Daily Emollient | 72.3 | Participants with imputed values | ||
| Atopic Dermatitis by UK Working Party Criteria | Natural Skin | 83.1 | Participants with imputed values | ||
| Atopic Dermatitis by Children's Eczema Questionnaire | Daily Emollient | 156.9 | Participants with imputed values | ||
| Atopic Dermatitis by Children's Eczema Questionnaire | Natural Skin | 195.3 | Participants with imputed values | ||
| Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart | Daily Emollient | 116.5 | Participants with imputed values | ||
| Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart | Natural Skin | 179.8 | Participants with imputed values |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daily Emollient | 623 | |
| Overall Study | STARTED | Natural Skin | 637 | |
| Overall Study | Enrolled Infants | Daily Emollient | 623 | |
| Overall Study | Enrolled Infants | Natural Skin | 637 | |
| Overall Study | Enrolled Parents | Daily Emollient | 623 | |
| Overall Study | Enrolled Parents | Natural Skin | 637 | |
| Overall Study | COMPLETED | Daily Emollient | 603 | |
| Overall Study | COMPLETED | Natural Skin | 625 | |
| Overall Study | NOT COMPLETED | Daily Emollient | 20 | |
| Overall Study | NOT COMPLETED | Natural Skin | 12 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eosinophilic pustular folliculitis | Blood and lymphatic system disorders | Daily Emollient | 0 | 614 | 0 |
| other | Eosinophilic pustular folliculitis | Blood and lymphatic system disorders | Natural Skin | 1 | 633 | 1 |
| other | Allergic reaction NOS, urticaria | Immune system disorders | Daily Emollient | 2 | 614 | 2 |
| other | Allergic reaction NOS, urticaria | Immune system disorders | Natural Skin | 4 | 633 | 4 |
| other | Acne infantile | Skin and subcutaneous tissue disorders | Daily Emollient | 2 | 614 | 3 |
| other | Acne infantile | Skin and subcutaneous tissue disorders | Natural Skin | 3 | 633 | 3 |
| other | Dermatitis acneiform | Skin and subcutaneous tissue disorders | Daily Emollient | 0 | 614 | 0 |
| other | Dermatitis acneiform | Skin and subcutaneous tissue disorders | Natural Skin | 1 | 633 | 1 |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Daily Emollient | 30 | 614 | 35 |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Natural Skin | 40 | 633 | 46 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daily Emollient | 1 | 614 |
| Total, all-cause mortality | Natural Skin | 1 | 633 |
| Total, other adverse events | Daily Emollient | 134 | 614 |
| Total, other adverse events | Natural Skin | 155 | 633 |
| Total, serious adverse events | Daily Emollient | 25 | 614 |
| Total, serious adverse events | Natural Skin | 39 | 633 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AR071057 | A Community-based Assessment of Skin Care, Allergies, and Eczema: The CASCADE Trial | SIMPSON, ERIC L | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2018 to 2023 |
Source NIH RePORTER
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daily Emollient vs Natural Skin: Primary Outcome of Provider-diagnosed Atopic Dermatitis | Trial comparisons |
| Daily Emollient vs Natural Skin: Skin Infections Diagnosed and Recorded in Chart Review | Trial comparisons |
| Daily Emollient vs Natural Skin: Provider-diagnosed Asthma | Trial comparisons |
| Daily Emollient vs Natural Skin: Provider-diagnosed Atopic Dermatitis at 18 Months | Trial comparisons |
| Daily Emollient vs Natural Skin: Food Allergy Symptoms | Trial comparisons |
| Daily Emollient vs Natural Skin: Food Allergy Diagnosis With Positive Test | Trial comparisons |
| Daily Emollient vs Natural Skin: deaths from any cause | Trial comparisons |
| Daily Emollient vs Natural Skin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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