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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis (AD)
• Intervention / Treatment: Drug: Experimental Product

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33714
      • Hill-top Research, Inc
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Experimental Product; 1% Colloidal Oatmeal Balm; Other Names: Eczema Moisturizing Balm
Experimental: 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	Drug: Experimental Product; 1% Colloidal Oatmeal Balm; Other Names: Eczema Moisturizing Balm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage With Erythema on the Face at Baseline Before Investigational Product Application	Percentage of adults and babies with erythema on the face at baseline before investigational product application	At baseline before investigational product application
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application	Percentage of adults and babies with erythema on the arms at baseline before investigational product application	At baseline before investigational product application
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application	Percentage of adults and babies with erythema on the legs at baseline before investigational product application	At baseline before investigational product application
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application	Percentage of adults and babies with erythema on the torso at baseline before investigational product application	At baseline before investigational product application
Percentage With Erythema on the Face at Baseline After Investigational Product Application	Percentage of adults and babies with erythema on the face at baseline after investigational product application	At baseline after investigational product application
Percentage With Erythema on the Arms at Baseline After Investigational Product Application	Percentage of adults and babies with erythema on the arms at baseline after investigational product application	At baseline after investigational product application
Percentage With Erythema on the Legs at Baseline After Investigational Product Application	Percentage of adults and babies with erythema on the legs at baseline after investigational product application	At baseline after investigational product application
Percentage With Erythema on the Torso at Baseline After Investigational Product Application	Percentage of adults and babies with erythema on the torso at baseline after investigational product application	At baseline after investigational product application
Percentage With Erythema on the Face at Day 1	Percentage of adults and babies with erythema on the face at Day 1	At Day 1
Percentage With Erythema on the Arms at Day 1	Percentage of adults and babies with erythema on the arms at Day 1	At Day 1
Percentage With Erythema on the Legs at Day 1	Percentage of adults and babies with erythema on the legs at Day 1	At Day 1
Percentage With Erythema on the Torso at Day 1	Percentage of adults and babies with erythema on the torso at Day 1	At Day 1
Percentage With Erythema on the Face at Day 7	Percentage of adults and babies with erythema on the face at Day 7	At Day 7
Percentage With Erythema on the Arms at Day 7	Percentage of adults and babies with erythema on the arms at Day 7	At Day 7
Percentage With Erythema on the Legs at Day 7	Percentage of adults and babies with erythema on the legs at Day 7	At Day 7
Percentage With Erythema on the Torso at Day 7	Percentage of adults and babies with erythema on the torso at Day 7	At Day 7
Percentage With Erythema on the Face at Day 14	Percentage of adults and babies with erythema on the face at Day 14	At Day 14
Percentage With Erythema on the Arms at Day 14	Percentage of adults and babies with erythema on the arms at Day 14	At Day 14
Percentage With Erythema on the Legs at Day 14	Percentage of adults and babies with erythema on the legs at Day 14	At Day 14
Percentage With Erythema on the Torso at Day 14	Percentage of adults and babies with erythema on the torso at Day 14	At Day 14
Percentage With Edema on the Face at Baseline Before Investigational Product Application	Percentage of adults and babies with edema on the face at baseline before investigational product application	At baseline before investigational product application
Percentage With Edema on the Arms at Baseline Before Investigational Product Application	Percentage of adults and babies with edema on the arms at baseline before investigational product application	At baseline before investigational product application
Percentage With Edema on the Legs at Baseline Before Investigational Product Application	Percentage of adults and babies with edema on the legs at baseline before investigational product application	At baseline before investigational product application
Percentage With Edema on the Torso at Baseline Before Investigational Product Application	Percentage of adults and babies with edema on the torso at baseline before investigational product application	At baseline before investigational product application
Percentage With Edema on the Face at Baseline After Investigational Product Application	Percentage of adults and babies with edema on the face at baseline after investigational product application	At baseline after investigational product application
Percentage With Edema on the Arms at Baseline After Investigational Product Application	Percentage of adults and babies with edema on the arms at baseline after investigational product application	At baseline after investigational product application
Percentage With Edema on the Legs at Baseline After Investigational Product Application	Percentage of adults and babies with edema on the legs at baseline after investigational product application	At baseline after investigational product application
Percentage With Edema on the Torso at Baseline After Investigational Product Application	Percentage of adults and babies with edema on the torso at baseline after investigational product application	At baseline after investigational product application
Percentage With Edema on the Face at Day 1	Percentage of adults and babies with edema on the face at Day 1	At Day 1
Percentage With Edema on the Arms at Day 1	Percentage of adults and babies with edema on the arms at Day 1	At Day 1
Percentage With Edema on the Legs at Day 1	Percentage of adults and babies with edema on the legs at Day 1	At Day 1
Percentage With Edema on the Torso at Day 1	Percentage of adults and babies with edema on the torso at Day 1	At Day 1
Percentage With Edema on the Face at Day 7	Percentage of adults and babies with edema on the face at Day 7	At Day 7
Percentage With Edema on the Arms at Day 7	Percentage of adults and babies with edema on the arms at Day 7	At Day 7
Percentage With Edema on the Legs at Day 7	Percentage of adults and babies with edema on the legs at Day 7	At Day 7
Percentage With Edema on the Torso at Day 7	Percentage of adults and babies with edema on the torso at Day 7	At Day 7
Percentage With Edema on the Face at Day 14	Percentage of adults and babies with edema on the face at Day 14	At Day 14
Percentage With Edema on the Arms at Day 14	Percentage of adults and babies with edema on the arms at Day 14	At Day 14
Percentage With Edema on the Legs at Day 14	Percentage of adults and babies with edema on the legs at Day 14	At Day 14
Percentage With Edema on the Torso at Day 14	Percentage of adults and babies with edema on the torso at Day 14	At Day 14
Percentage With Scaling on the Face at Baseline Before Investigational Product Application	Percentage of adults and babies with scaling on the face at baseline before investigational product application	At baseline before investigational product application
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application	Percentage of adults and babies with scaling on the arms at baseline before investigational product application	At baseline before investigational product application
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application	Percentage of adults and babies with scaling on the legs at baseline before investigational product application	At baseline before investigational product application
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application	Percentage of adults and babies with scaling on the torso at baseline before investigational product application	At baseline before investigational product application
Percentage With Scaling on the Face at Baseline After Investigational Product Application	Percentage of adults and babies with scaling on the face at baseline after investigational product application	At baseline after investigational product application
Percentage With Scaling on the Arms at Baseline After Investigational Product Application	Percentage of adults and babies with scaling on the arms at baseline after investigational product application	At baseline after investigational product application
Percentage With Scaling on the Legs at Baseline After Investigational Product Application	Percentage of adults and babies with scaling on the legs at baseline after investigational product application	At baseline after investigational product application
Percentage With Scaling on the Torso at Baseline After Investigational Product Application	Percentage of adults and babies with scaling on the torso at baseline after investigational product application	At baseline after investigational product application
Percentage With Scaling on the Face at Day 1	Percentage of adults and babies with scaling on the face at Day 1	At Day 1
Percentage With Scaling on the Arms at Day 1	Percentage of adults and babies with scaling on the arms at Day 1	At Day 1
Percentage With Scaling on the Legs at Day 1	Percentage of adults and babies with scaling on the legs at Day 1	At Day 1
Percentage With Scaling on the Torso at Day 1	Percentage of adults and babies with scaling on the torso at Day 1	At Day 1
Percentage With Scaling on the Face at Day 7	Percentage of adults and babies with scaling on the face at Day 7	At Day 7
Percentage With Scaling on the Arms at Day 7	Percentage of adults and babies with scaling on the arms at Day 7	At Day 7
Percentage With Scaling on the Legs at Day 7	Percentage of adults and babies with scaling on the legs at Day 7	At Day 7
Percentage With Scaling on the Torso at Day 7	Percentage of adults and babies with scaling on the torso at Day 7	At Day 7
Percentage With Scaling on the Face at Day 14	Percentage of adults and babies with scaling on the face at Day 14	At Day 14
Percentage With Scaling on the Arms at Day 14	Percentage of adults and babies with scaling on the arms at Day 14	At Day 14
Percentage With Scaling on the Legs at Day 14	Percentage of adults and babies with scaling on the legs at Day 14	At Day 14
Percentage With Scaling on the Torso at Day 14	Percentage of adults and babies with scaling on the torso at Day 14	At Day 14

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Study Director: Amisha Parikh-Das, Ph.D., Johnson & Johnson Consumer Inc. (J&JCI); Principal Investigator: Daniel Hogan, M.D., Hill-top Research Inc.; Principal Investigator: Ethlynn Schorr, M.D., TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: November 18, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Eczema; Skin Irritation
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CO-140908134135-SBCT