Trial Outcomes & Findings for The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis (NCT NCT00179959)

Results Overview

The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician's Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2014-12-08

Participant Flow

Patients were recruited from Children's Memorial Hospital's pediatric dermatology clinic.

Participant milestones

Participant milestones
Measure	Treatment Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)	Placebo Intranasal petrolatum ointment treatment and plain water baths
Overall Study STARTED	15	16
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)	Placebo Intranasal petrolatum ointment treatment and plain water baths
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=15 Participants Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)	Placebo n=16 Participants Intranasal petrolatum ointment treatment and plain water baths	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	16 participants n=4 Participants	31 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Analysis was per protocol.

The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician's Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).

Outcome measures

Outcome measures
Measure	Treatment n=9 Participants Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)	Placebo n=13 Participants Intranasal petrolatum ointment treatment and plain water baths
Change in Eczema Area and Severity Index (EASI)Scores According to Location Exposed Sites: Head and Neck	-1.06 Change in EASI Score Standard Deviation 1.04	-0.57 Change in EASI Score Standard Deviation 0.86
Change in Eczema Area and Severity Index (EASI)Scores According to Location Bath-Submerged Sites: Limbs and Trunk	-4.94 Change in EASI Score Standard Deviation 0.74	-0.88 Change in EASI Score Standard Deviation 0.62

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=15 participants at risk Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)	Placebo n=16 participants at risk Intranasal petrolatum ointment treatment and plain water baths
Skin and subcutaneous tissue disorders Itching and Irritation	6.7% 1/15 • Number of events 1 • 3 months	0.00% 0/16 • 3 months

Additional Information

Amy Paller, MD

Children's Memorial Hospital

Phone: 312-695-6829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place