Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin

NCT ID: NCT02404493

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

Brief Summary

The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.

Detailed Description

50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group.

Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas.

Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

EpiCeram Skin Barrier Emulsion

Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin.

Group Type: ACTIVE_COMPARATOR

EpiCeram Skin Barrier Emulsion

Intervention Type: DEVICE

EpiCeram Skin Barrier Emulsion

1% Colloidal Oatmeal Balm

Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin.

Group Type: EXPERIMENTAL

1% Colloidal Oatmeal Balm

Intervention Type: DRUG

Experimental Product 1% Colloidal Oatmeal Balm

Interventions

EpiCeram Skin Barrier Emulsion

EpiCeram Skin Barrier Emulsion

Intervention Type: DEVICE

1% Colloidal Oatmeal Balm

Experimental Product 1% Colloidal Oatmeal Balm

Intervention Type: DRUG

Other Intervention Names

Eczema Moisturizing Balm

Eligibility Criteria

Inclusion Criteria

1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)

2. Male or female of any race or ethnicity, 6 months to 47 months of age;

3. Diagnosed as having eczema

4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study

5. Child must have bedtime/sleep issues due to their dry, itchy skin

Exclusion Criteria

1. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema

2. Participation in any clinical study within 30 days of Visit 1

3. Active infection of any type at the start of the study

4. Diagnosed as having severe eczema

5. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids

6. Child wakes up 3 or more times during the night

7. Child is awake more than 60 minutes during the night

8. Child sleeps for less than a total of 9 hours (during the day or night)

9. Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 47 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amisha Parikh-Das, PhD

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer Inc. (J&JCI)

Ethlynn Schorr, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research, Inc.

Locations

TKL Research

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

CO-141020101115-THCT

Identifier Type: -

Identifier Source: org_study_id