Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

NCT ID: NCT02357940

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Detailed Description

At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adult Tolerance Assessment

Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin

Group Type: EXPERIMENTAL

Experimental Product

Intervention Type: DRUG

1% Colloidal Oatmeal Balm

Baby (infants, toddlers, young children) Tolerance Assessment

Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin

Group Type: EXPERIMENTAL

Experimental Product

Intervention Type: DRUG

1% Colloidal Oatmeal Balm

Interventions

Experimental Product

1% Colloidal Oatmeal Balm

Intervention Type: DRUG

Other Intervention Names

Eczema Moisturizing Balm

Eligibility Criteria

Inclusion Criteria

1. Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above.

2. Adult subjects only - Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partners use of a highly effective form of birth control for 3 months.

3. Diagnosed as having Eczema.

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

5. Willing to not introduce any new fragrances (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, laundry detergents, etc.) for the duration of the study.

6. Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing.

7. Willing to not enter/use hot tub or whirlpool bath for the duration of the study.

8. Willing to avoid the beach during the course of the study, and willing to document any activities at or in a swimming pool in the daily diary.

Exclusion Criteria

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

2. Adults Females who are pregnant (self-reported) or breastfeeding.

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

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

5. Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids.

6. Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.

7. Subjects who are currently on phototherapy.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amisha Parikh-Das, Ph.D.

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer Inc. (J&JCI)

Daniel Hogan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hill-top Research Inc.

Ethlynn Schorr, M.D.

Role: PRINCIPAL_INVESTIGATOR

TKL Research, Inc.

Locations

Hill-top Research, Inc

St. Petersburg, Florida, United States

TKL Research Inc.

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

CO-140908134135-SBCT

Identifier Type: -

Identifier Source: org_study_id