A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin

NCT02120833 | Completed Phase 3 Results

• 1 other identifier: CO-140206110636-SBCT
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study. Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study. One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14. Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.

Conditions

Eczema

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline

  The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.

  Baseline to Day 3

• Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline

  The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.

  Baseline to Day 3

Secondary Outcomes (73)

• Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline

  Baseline to Day 1

• Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline

  Baseline to Day 2

• Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline

  Baseline to Day 7

• Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline

  Baseline to Day 14

• Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline

  Baseline to Day 1

Study Arms (2)

EPI

ACTIVE COMPARATOR

Device: EpiCeram® Skin Barrier Emulsion

NEE

EXPERIMENTAL

Drug: Colloidal Oatmeal Cream

Interventions

EpiCeram® Skin Barrier Emulsion DEVICE

Device (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.

EPI

Colloidal Oatmeal Cream DRUG

Drug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.

NEE

Eligibility Criteria

• Age: 2 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
• Caregiver is able and willing to provide written informed consent for the participant to participate in the trial;
• Male or female of any race or ethnicity, 2 months to 35 months of age;
• Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by Hanifin and Rajka
• Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per Rajka-Langeland severity index
• Willing to stop all emollients, moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period. If using corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be on a stable dose for a minimum of 1 month;
• Willing to undergo a washout period of 2 days before the trial initiation where no use of moisturizers or emollients will be allowed; and
• Willing and able to comply with scheduled visits, treatment plan, and other trial procedures.

You may not qualify if:

• Known sensitivity to any investigational product ingredient;
• Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema;
• Participation in any clinical study within 30 days of Visit 1;
• Relative, partner or staff of any clinical research site personnel;
• Active infection of any type at the start of the study;
• Severe AD as determined by the Rajka-Langeland Severity Index
• AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If a participant requires any of these medications as rescue therapy during the study, the participant will be discontinued from the trial;
• Requires any inhaled or intranasal corticosteroids;
• Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (2)

Thomas J. Stephens and Associates, Colorado Research Center

Colorado Springs, Colorado, 80915, United States

Location

Thomas J. Stephens and Associates, Dallas Research Center

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chirstopher Nunez, PhD/Study Director
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

cnunez1@its.jnj.com

973-385-7984 USA EST

Study Officials

• Christopher Nunez

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 23, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 13, 2017
• Results First Posted: September 7, 2015

Record last verified: 2017-01

Locations

US (2)