NCT01375205

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 12, 2019

Completed
Last Updated

February 12, 2020

Status Verified

January 1, 2020

Enrollment Period

3.3 years

First QC Date

June 15, 2011

Results QC Date

January 22, 2019

Last Update Submit

January 30, 2020

Conditions

Atopic Dermatitis

Keywords

atopic dermatitisskin care

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months

    Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months

    12 months

Secondary Outcomes (6)

  • Percentage of High Emollient Use

    2, 6, 12, 18, and 24 months

  • Age at Onset of Eczema

    Baseline through Month 24 Follow-up

  • Filaggrin Mutation Status

    6 month visit

  • Transepidermal Water Loss (TEWL)

    2 month, 6 month, and 12 month visits

  • Skin Hydration (Skin Electrical Capacitance)

    2 month, 6 month, and 12 month visits

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser.

Other: Standard of Care

Cetaphil Restoraderm

EXPERIMENTAL

Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.

Other: Cetaphil Restoraderm

Interventions

Cetaphil RestoradermOTHER

Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.

Cetaphil Restoraderm
Standard of CareOTHER

Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser.

Also known as: Johnson&Johnson
Standard of Care

Eligibility Criteria

Age1 Day - 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Standard of CareAd26COVS1

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationCOVID-19 VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Eric Simpson, MD, MCR
Organization
Oregon Health & Science University
simpsone@ohsu.edu
503-494-3968

Study Officials

  • Eric Simpson, MD, MCR

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., M.C.R.

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 17, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2014

Study Completion

November 1, 2015

Last Updated

February 12, 2020

Results First Posted

April 12, 2019

Record last verified: 2020-01

Locations

US(1)