N/A
N=41
Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema
Atopic Dermatitis (AD)
Bottom Line
View on ClinicalTrials.gov: NCT02357940 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Percentage With Erythema on the Face at Baseline Before Investigational Product Application — 33.3; 71.9; 55.6; 6.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Product (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage With Erythema on the Face at Baseline Before Investigational Product Application |
33.3; 71.9; 55.6; 6.3; 11.1; 21.9 | — |
| PRIMARY Percentage With Erythema on the Arms at Baseline Before Investigational Product Application |
55.6; 65.6; 22.2; 9.4; 0.0; 18.8 | — |
| PRIMARY Percentage With Erythema on the Legs at Baseline Before Investigational Product Application |
33.3; 62.5; 33.3; 9.4; 11.1; 25.0 | — |
| PRIMARY Percentage With Erythema on the Torso at Baseline Before Investigational Product Application |
55.6; 84.4; 22.2; 0.0; 22.2; 12.5 | — |
| PRIMARY Percentage With Erythema on the Face at Baseline After Investigational Product Application |
55.6; 75.0; 33.3; 6.3; 11.1; 18.8 | — |
| PRIMARY Percentage With Erythema on the Arms at Baseline After Investigational Product Application |
55.6; 68.8; 22.2; 12.5; 0.0; 15.6 | — |
| PRIMARY Percentage With Erythema on the Legs at Baseline After Investigational Product Application |
44.4; 68.8; 22.2; 9.4; 11.1; 18.8 | — |
| PRIMARY Percentage With Erythema on the Torso at Baseline After Investigational Product Application |
55.6; 90.6; 22.2; 0.0; 22.2; 3.1 | — |
| PRIMARY Percentage With Erythema on the Face at Day 1 |
55.6; 87.5; 44.4; 3.1; 0.0; 9.4 | — |
| PRIMARY Percentage With Erythema on the Arms at Day 1 |
44.4; 78.1; 22.2; 3.1; 11.1; 18.8 | — |
| PRIMARY Percentage With Erythema on the Legs at Day 1 |
44.4; 75.0; 22.2; 15.6; 22.2; 9.4 | — |
| PRIMARY Percentage With Erythema on the Torso at Day 1 |
44.4; 75.0; 33.3; 3.1; 22.2; 18.8 | — |
| PRIMARY Percentage With Erythema on the Face at Day 7 |
22.2; 77.4; 55.6; 6.5; 22.2; 16.1 | — |
| PRIMARY Percentage With Erythema on the Arms at Day 7 |
33.3; 77.4; 33.3; 3.2; 22.2; 19.4 | — |
| PRIMARY Percentage With Erythema on the Legs at Day 7 |
33.3; 83.9; 55.6; 3.2; 0.0; 12.9 | — |
| PRIMARY Percentage With Erythema on the Torso at Day 7 |
33.3; 87.1; 44.4; 3.2; 22.2; 9.7 | — |
| PRIMARY Percentage With Erythema on the Face at Day 14 |
44.4; 76.7; 55.6; 6.7; 0.0; 16.7 | — |
| PRIMARY Percentage With Erythema on the Arms at Day 14 |
44.4; 83.3; 44.4; 6.7; 11.1; 10.0 | — |
| PRIMARY Percentage With Erythema on the Legs at Day 14 |
55.6; 80.0; 33.3; 10.0; 0.0; 6.7 | — |
| PRIMARY Percentage With Erythema on the Torso at Day 14 |
44.4; 86.7; 33.3; 3.3; 11.1; 10.0 | — |
| PRIMARY Percentage With Edema on the Face at Baseline Before Investigational Product Application |
66.7; 90.6; 33.3; 6.3; 0.0; 3.1 | — |
| PRIMARY Percentage With Edema on the Arms at Baseline Before Investigational Product Application |
66.7; 81.3; 0.0; 6.3; 11.1; 9.4 | — |
| PRIMARY Percentage With Edema on the Legs at Baseline Before Investigational Product Application |
22.2; 81.3; 44.4; 3.1; 11.1; 6.3 | — |
| PRIMARY Percentage With Edema on the Torso at Baseline Before Investigational Product Application |
44.4; 84.4; 22.2; 6.3; 22.2; 3.1 | — |
| PRIMARY Percentage With Edema on the Face at Baseline After Investigational Product Application |
77.8; 87.5; 22.2; 9.4; 0.0; 3.1 | — |
| PRIMARY Percentage With Edema on the Arms at Baseline After Investigational Product Application |
66.7; 87.5; 11.1; 3.1; 0.0; 6.3 | — |
| PRIMARY Percentage With Edema on the Legs at Baseline After Investigational Product Application |
44.4; 84.4; 22.2; 3.1; 11.1; 6.3 | — |
| PRIMARY Percentage With Edema on the Torso at Baseline After Investigational Product Application |
66.7; 87.5; 0.0; 3.1; 22.2; 6.3 | — |
| PRIMARY Percentage With Edema on the Face at Day 1 |
88.9; 96.9; 11.1; 0.0; 0.0; 3.1 | — |
| PRIMARY Percentage With Edema on the Arms at Day 1 |
55.6; 90.6; 11.1; 6.3; 22.2; 3.1 | — |
| PRIMARY Percentage With Edema on the Legs at Day 1 |
33.3; 90.6; 44.4; 6.3; 11.1; 0.0 | — |
| PRIMARY Percentage With Edema on the Torso at Day 1 |
66.7; 90.6; 0.0; 6.3; 22.2; 3.1 | — |
| PRIMARY Percentage With Edema on the Face at Day 7 |
55.6; 93.5; 33.3; 6.5; 11.1; 0.0 | — |
| PRIMARY Percentage With Edema on the Arms at Day 7 |
44.4; 93.5; 22.2; 6.5; 22.2; 0.0 | — |
| PRIMARY Percentage With Edema on the Legs at Day 7 |
33.3; 87.1; 55.6; 6.5; 0.0; 3.2 | — |
| PRIMARY Percentage With Edema on the Torso at Day 7 |
66.7; 93.5; 0.0; 3.2; 11.1; 3.2 | — |
| PRIMARY Percentage With Edema on the Face at Day 14 |
77.8; 93.3; 22.2; 0.0; 0.0; 6.7 | — |
| PRIMARY Percentage With Edema on the Arms at Day 14 |
55.6; 83.3; 22.2; 3.3; 22.2; 10.0 | — |
| PRIMARY Percentage With Edema on the Legs at Day 14 |
44.4; 80.0; 44.4; 6.7; 0.0; 13.3 | — |
| PRIMARY Percentage With Edema on the Torso at Day 14 |
33.3; 83.3; 44.4; 13.3; 0.0; 3.3 | — |
| PRIMARY Percentage With Scaling on the Face at Baseline Before Investigational Product Application |
66.7; 81.3; 33.3; 9.4; 0.0; 6.3 | — |
| PRIMARY Percentage With Scaling on the Arms at Baseline Before Investigational Product Application |
11.1; 56.3; 33.3; 3.1; 33.3; 28.1 | — |
| PRIMARY Percentage With Scaling on the Legs at Baseline Before Investigational Product Application |
0.0; 34.4; 22.2; 6.3; 44.4; 31.3 | — |
| PRIMARY Percentage With Scaling on the Torso at Baseline Before Investigational Product Application |
22.2; 71.9; 66.7; 6.3; 11.1; 12.5 | — |
| PRIMARY Percentage With Scaling on the Face at Baseline After Investigational Product Application |
77.8; 90.6; 22.2; 6.3; 0.0; 0.0 | — |
| PRIMARY Percentage With Scaling on the Arms at Baseline After Investigational Product Application |
33.3; 71.9; 44.4; 12.5; 22.2; 12.5 | — |
| PRIMARY Percentage With Scaling on the Legs at Baseline After Investigational Product Application |
22.2; 56.3; 66.7; 21.9; 11.1; 18.8 | — |
| PRIMARY Percentage With Scaling on the Torso at Baseline After Investigational Product Application |
55.6; 78.1; 44.4; 15.6; 0.0; 6.3 | — |
| PRIMARY Percentage With Scaling on the Face at Day 1 |
66.7; 84.4; 33.3; 6.3; 0.0; 9.4 | — |
| PRIMARY Percentage With Scaling on the Arms at Day 1 |
44.4; 75.0; 33.3; 9.4; 11.1; 9.4 | — |
| PRIMARY Percentage With Scaling on the Legs at Day 1 |
11.1; 53.1; 66.7; 18.8; 11.1; 18.8 | — |
| PRIMARY Percentage With Scaling on the Torso at Day 1 |
33.3; 81.3; 66.7; 6.3; 0.0; 9.4 | — |
| PRIMARY Percentage With Scaling on the Face at Day 7 |
55.6; 80.6; 44.4; 3.2; 0.0; 16.1 | — |
| PRIMARY Percentage With Scaling on the Arms at Day 7 |
44.4; 74.2; 55.6; 12.9; 0.0; 9.7 | — |
| PRIMARY Percentage With Scaling on the Legs at Day 7 |
0.0; 64.5; 44.4; 16.1; 44.4; 12.9 | — |
| PRIMARY Percentage With Scaling on the Torso at Day 7 |
44.4; 80.6; 44.4; 12.9; 11.1; 6.5 | — |
| PRIMARY Percentage With Scaling on the Face at Day 14 |
66.7; 83.3; 33.3; 6.7; 0.0; 10.0 | — |
| PRIMARY Percentage With Scaling on the Arms at Day 14 |
33.3; 80.0; 44.4; 0.0; 11.1; 13.3 | — |
| PRIMARY Percentage With Scaling on the Legs at Day 14 |
22.2; 70.0; 44.4; 6.7; 22.2; 20.0 | — |
| PRIMARY Percentage With Scaling on the Torso at Day 14 |
33.3; 80.0; 66.7; 13.3; 0.0; 6.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above.
- 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.
- Diagnosed as having Eczema.
- Willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study.
- 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.
- Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing.
- Willing to not enter/use hot tub or whirlpool bath for the duration of the study.
- 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
- Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
- Adults Females who are pregnant (self-reported) or breastfeeding.
- Participation in any clinical study within 30 days of Visit 1.
- Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids.
- Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids.
- Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
- Subjects who are currently on phototherapy.
Data sourced from ClinicalTrials.gov (NCT02357940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.