Trial Outcomes & Findings for Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema (NCT NCT01326910)

NCT ID: NCT01326910

Last Updated: 2012-08-03

Results Overview

A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2012-08-03

Participant Flow

Participant milestones

Measure	19306-127 Experimental Topical cream applied twice daily (or as needed)	19306-137 Marketed Topical cream applied twice daily (or as needed)
Overall Study STARTED	45	45
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	19306-127 Experimental Topical cream applied twice daily (or as needed)	19306-137 Marketed Topical cream applied twice daily (or as needed)
Overall Study Withdrawal by Subject	3	2
Overall Study Protocol Violation	1	1

Baseline Characteristics

Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

Baseline characteristics by cohort

Measure	19306-127 n=45 Participants Experimental Topical cream applied twice daily (or as needed)	19306-137 n=45 Participants Marketed Topical cream applied twice daily (or as needed)	Total n=90 Participants Total of all reporting groups
Age Continuous	6.9 years STANDARD_DEVIATION 3.26 • n=5 Participants	9.3 years STANDARD_DEVIATION 4.26 • n=7 Participants	8.1 years STANDARD_DEVIATION 3.96 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: Intention to Treat (ITT)

A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72

Outcome measures

Measure	19306-127 n=45 Participants Experimental Topical cream applied twice daily (or as needed)	19306-137 n=45 Participants Marketed Topical cream applied twice daily (or as needed)
Eczema Area and Severity Index (EASI) Day 0, Baseline	3.014 units on a scale Standard Deviation 1.9473	3.359 units on a scale Standard Deviation 3.6925
Eczema Area and Severity Index (EASI) Day 7, Week 1	1.286 units on a scale Standard Deviation 1.0137	1.621 units on a scale Standard Deviation 1.9275
Eczema Area and Severity Index (EASI) Day 14, Week 2	1.310 units on a scale Standard Deviation 2.0153	1.298 units on a scale Standard Deviation 1.5811
Eczema Area and Severity Index (EASI) Day 21, Week 3	1.154 units on a scale Standard Deviation 1.1570	1.064 units on a scale Standard Deviation 1.1320

SECONDARY outcome

Timeframe: Week 2

Population: Intention to Treat

Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.

Outcome measures

Measure	19306-127 n=41 Participants Experimental Topical cream applied twice daily (or as needed)	19306-137 n=42 Participants Marketed Topical cream applied twice daily (or as needed)
Interim Eczema Area and Severity Index (EASI) Improved	38 participants 1.8789	38 participants 2.8447
Interim Eczema Area and Severity Index (EASI) Not Improved	3 participants	4 participants

SECONDARY outcome

Timeframe: through Week 3

Population: Intention to Treat (ITT)

Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable

Outcome measures

Measure	19306-127 n=45 Participants Experimental Topical cream applied twice daily (or as needed)	19306-137 n=45 Participants Marketed Topical cream applied twice daily (or as needed)
Assessment of Itch Day 14, Week 2	2.199 units on a scale Standard Deviation 2.4595	1.480 units on a scale Standard Deviation 2.1464
Assessment of Itch Day 0, Baseline	1.557 units on a scale Standard Deviation 2.2526	1.208 units on a scale Standard Deviation 2.4939
Assessment of Itch Day 7, Week 1	1.840 units on a scale Standard Deviation 2.2876	1.537 units on a scale Standard Deviation 2.2051
Assessment of Itch Day 21, Week 3	1.972 units on a scale Standard Deviation 2.7890	1.685 units on a scale Standard Deviation 2.5902

SECONDARY outcome

Timeframe: through Week 3

Population: Intention to Treat (ITT)

An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.

Outcome measures

Measure	19306-127 n=45 Participants Experimental Topical cream applied twice daily (or as needed)	19306-137 n=45 Participants Marketed Topical cream applied twice daily (or as needed)
Investigator's Global Atopic Dermatitis Assessment (IGADA) Day 0, Baseline	2.159 units on a scale Standard Deviation 0.6078	2.182 units on a scale Standard Deviation 0.6567
Investigator's Global Atopic Dermatitis Assessment (IGADA) Day 7, Week 1	1.690 units on a scale Standard Deviation 0.6803	1.667 units on a scale Standard Deviation 0.7861
Investigator's Global Atopic Dermatitis Assessment (IGADA) Day 14, Week 2	1.585 units on a scale Standard Deviation 0.7062	1.548 units on a scale Standard Deviation 0.8025
Investigator's Global Atopic Dermatitis Assessment (IGADA) Day 21, Week 3	1.585 units on a scale Standard Deviation 0.8055	1.381 units on a scale Standard Deviation 0.7949

Adverse Events

19306-127

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

19306-137

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	19306-127 n=45 participants at risk Experimental Topical cream applied twice daily (or as needed)	19306-137 n=45 participants at risk Marketed Topical cream applied twice daily (or as needed)
Skin and subcutaneous tissue disorders PRURITUS	4.4% 2/45 • Three Weeks plus 30 days for Serious Adverse Events	2.2% 1/45 • Three Weeks plus 30 days for Serious Adverse Events
Skin and subcutaneous tissue disorders RASH PRURITIC	2.2% 1/45 • Three Weeks plus 30 days for Serious Adverse Events	0.00% 0/45 • Three Weeks plus 30 days for Serious Adverse Events
General disorders PYREXIA	4.4% 2/45 • Three Weeks plus 30 days for Serious Adverse Events	0.00% 0/45 • Three Weeks plus 30 days for Serious Adverse Events
Immune system disorders SEASONAL ALLERGY	2.2% 1/45 • Three Weeks plus 30 days for Serious Adverse Events	0.00% 0/45 • Three Weeks plus 30 days for Serious Adverse Events
Infections and infestations EAR INFECTION	0.00% 0/45 • Three Weeks plus 30 days for Serious Adverse Events	2.2% 1/45 • Three Weeks plus 30 days for Serious Adverse Events

Additional Information

Joyce Hauze, Sr. Specialist Clinical Quality Systems and Process

Johnson & Johnson Consumer and Personal Products Worldwide

Phone: 928-277-0715

Email: jhauze@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee The trial was conducted as work made for hire, and disclosure of results by the investigator is prohibited without the prior written consent of Sponsor.
• Publication restrictions are in place

Restriction type: OTHER