An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

NCT01375205

Atopic Dermatitis

COMPLETED NA

Short-term Topical Application to Prevent Atopic Dermatitis

NCT03871998

Eczema Atopic Dermatitis Eczema Eczema, Infantile +1 more

COMPLETED NA

Feasibility Study of Barrier Enhancement for Eczema Prevention

NCT01142999

Eczema

UNKNOWN NA

Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis

NCT07146971

Atopic Dermatitis (AD)

ENROLLING_BY_INVITATION PHASE3

Barrier Enhancement for Eczema Prevention

NCT04680520

Eczema

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Emollient

Skin barrier protection from birth

Group Type EXPERIMENTAL

emollient (Cetaphil cream)

Intervention Type DRUG

Cetaphil cream applied daily from birth

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

emollient (Cetaphil cream)

Cetaphil cream applied daily from birth

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* at least one parent diagnosed with Atopic Dermatitis
* one parent or sibling with hayfever or asthma

Exclusion Criteria

* newborns with dermatitis at birth
* newborns born greater than four weeks prematurely
* newborns with medical problems necessitating prolonged hospitalization
* newborns diagnosed with any immune deficiency syndrome

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No