Trial Outcomes & Findings for Combination Therapy for Atopic Dermatitis (NCT NCT00119158)

Results Overview

Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification. Total score 0-12

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

up to 15 days

Results posted on

2010-07-27

Participant Flow

Medical clinics at academic centers

Patients are self controls. Equivalent areas of eczema were compared

Participant milestones

Participant milestones
Measure	Active Therapy Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day	Placebo Arm Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
Active Treatment STARTED	45	45
Active Treatment COMPLETED	45	45
Active Treatment NOT COMPLETED	0	0
Placebo Treatment STARTED	45	45
Placebo Treatment COMPLETED	45	45
Placebo Treatment NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Therapy for Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Therapy n=45 Participants Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day	Placebo Arm n=45 Participants Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	16.2 years STANDARD_DEVIATION 17.4 • n=93 Participants	16.2 years STANDARD_DEVIATION 17.4 • n=4 Participants	16.2 years STANDARD_DEVIATION 17.4 • n=27 Participants
Sex: Female, Male Female	27 Participants n=93 Participants	27 Participants n=4 Participants	54 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Region of Enrollment United States	45 participants n=93 Participants	45 participants n=4 Participants	90 participants n=27 Participants

PRIMARY outcome

Timeframe: up to 15 days

Population: Analysis was per protocol, last observation carried forward

Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification. Total score 0-12

Outcome measures

Outcome measures
Measure	Active Therapy n=45 Participants Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day	Placebo Arm n=45 Participants Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
Change From Baseline in the m-EASI (Eczema Area Severity Index) Score.	5.04 units of a 0-12 scale Standard Deviation 2.7	4.77 units of a 0-12 scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: assessed up to 30 days following drug application

The time to clearance of eczema measured in days

Outcome measures

Outcome measures
Measure	Active Therapy n=45 Participants Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day	Placebo Arm n=45 Participants Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
The Time to Clearance of the Disease	9.22 days Standard Error 4.5	7.88 days Standard Error 3.88

SECONDARY outcome

Timeframe: up to one week

Time to partial clearance of the localized eczema lesion assessed by the investigator is measured in days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 15 days

The Investigator Global Assessment (IGA) and l-IGA were graded on a scale of 0-4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe). The percentage of eczema lesions from the total population that reach almost clear

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 15 days

The percentage of eczema areas that show improvement in l-IGA score. The l-IGA were graded on a scale of 0-4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to one week

The EASI is a measure of Atopic Dermatitis (AD) severity. A m-EASI score (0-12) was also calculated as the sum of severity (0 = mild to 3 = severe) for four separate AD symptoms: erythema, infiltration ⁄population, excoriation and lichenification. The percentage of participants whose eczema reaches almost clear

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

The patient or caregiver assessment of eczema severity (PSA) was recorded daily in a diary using a 0-4 scale similar to that of the IGA.(0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease,4 = severe disease). Difference in value of PSA from baseline to end of study

Outcome measures

Outcome data not reported

Adverse Events

Active Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Spergel

The Children's Hospital of Philadelphia

Phone: 215 590 1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place