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

Atopic Dermatitis (AD) Clinical Trial

Official title:

Clinical Trial to Evaluate the Tolerance of a Nighttime Moisturizing Balm on Babies and Adults With Mild to Moderate Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357940
• Other study ID #: CO-140908134135-SBCT
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: February 3, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Department of Health and Human Services (DHHS)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis (AD)
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Experimental Product
1% Colloidal Oatmeal Balm

Locations

Country	Name	City	State
United States	TKL Research Inc.	Fair Lawn,	New Jersey
United States	Hill-top Research, Inc	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at baseline, 5-10 minutes after first application.; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0= none; mild; moderate; severe (Half-point scores can be used)	Baseline	Yes
Primary	Adult Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at Day 1.; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0=none; mild; moderate; severe (Half-point scores can be used)	Day 1	Yes
Primary	Adult Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at Day 7.; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0=none; mild; moderate; severe (Half-point scores can be used)	Day 7	Yes
Primary	Adult Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at Day 14.; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0=none; mild; moderate; severe (Half-point scores can be used)	Day 14	Yes
Primary	Baby (infants, toddlers and young children) Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at baseline, 5-10 minutes after first application.; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0= none; mild; moderate; severe (Half-point scores can be used)	Baseline	Yes
Primary	Baby (infants, toddlers and young children) Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at Day 1.; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0= none; mild; moderate; severe (Half-point scores can be used)	Day 1	Yes
Primary	Baby (infants, toddlers and young children) Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at Day 7..; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0= none; mild; moderate; severe (Half-point scores can be used)	Day 7	Yes
Primary	Baby (infants, toddlers and young children) Tolerance Assessment	Face (cheek only), legs, arms, and torso will be assessed at Day 14.; Examiner assessment of irritation (erythema, edema and scaling) will be made using the following scale: 0= none; mild; moderate; severe (Half-point scores can be used)	Day 14	Yes