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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: Experimental Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02357940

CO-140908134135-SBCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Adult Tolerance Assessment

Experimental group

Description:

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

Treatment:

Drug: Experimental Product

Baby (infants, toddlers, young children) Tolerance Assessment

Experimental group

Description:

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

Treatment:

Drug: Experimental Product