Trial Outcomes & Findings for Management of Pruritus With Xyzal in Atopic Dermatitis (NCT NCT00884325)
NCT ID: NCT00884325
Last Updated: 2013-08-16
Results Overview
Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.
COMPLETED
PHASE4
40 participants
Baseline - Week 2-Week 4
2013-08-16
Participant Flow
Subjects with uncomplicated atopic dermatitis were recruited form the PI's medical practice. Recruitment occurred from March 2009 through December 2009.
45 subjects were consented but 5 were screen failures.
Participant milestones
| Measure |
Subjects Receiving Xyzal
one tablet, 5 mg, taken orally at night for 28 days
|
Subjects Receiving Placebo
one tablet taken orally at night for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Subjects Receiving Xyzal
one tablet, 5 mg, taken orally at night for 28 days
|
Subjects Receiving Placebo
one tablet taken orally at night for 28 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Not provided
|
1
|
0
|
Baseline Characteristics
Management of Pruritus With Xyzal in Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Subjects Receiving Xyzal
n=20 Participants
|
Subjects Receiving Placebo
n=20 Participants
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Age Categorical
Between 18 and 65 years
|
19 participants
n=93 Participants
|
18 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Age Categorical
>=65 years
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Age Continuous
|
41.1 years
FULL_RANGE 14.6 • n=93 Participants
|
41.1 years
FULL_RANGE 14.8 • n=4 Participants
|
41.1 years
FULL_RANGE 14.6 • n=27 Participants
|
|
Gender
Female
|
14 participants
n=93 Participants
|
12 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Gender
Male
|
6 participants
n=93 Participants
|
7 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline - Week 2-Week 4Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.
Outcome measures
| Measure |
Subjects Receiving Xyzal
n=20 Participants
|
Subjects Receiving Placebo
n=20 Participants
|
|---|---|---|
|
Pruritus VAS Scores at Baseline, Week 2 and Week 4
Baseline
|
7.8 units on a scale
Interval 6.5 to 8.5
|
7.5 units on a scale
Interval 7.0 to 8.0
|
|
Pruritus VAS Scores at Baseline, Week 2 and Week 4
Week 2
|
6.10 units on a scale
Interval 1.6 to 7.5
|
5.9 units on a scale
Interval 3.65 to 7.75
|
|
Pruritus VAS Scores at Baseline, Week 2 and Week 4
Week 4
|
4.15 units on a scale
Interval 2.4 to 6.9
|
6.4 units on a scale
Interval 2.5 to 7.3
|
SECONDARY outcome
Timeframe: Baseline - Week 2 - Week 4Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30)
Outcome measures
| Measure |
Subjects Receiving Xyzal
n=20 Participants
|
Subjects Receiving Placebo
n=20 Participants
|
|---|---|---|
|
Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
DLQI - Baseline
|
7.5 units on a scale
Interval 4.0 to 14.0
|
8.00 units on a scale
Interval 7.0 to 13.0
|
|
Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
DLQI - Week 2
|
3.5 units on a scale
Interval 2.0 to 6.5
|
5.5 units on a scale
Interval 2.0 to 9.0
|
|
Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
DLQI - Week 4
|
2.00 units on a scale
Interval 1.0 to 5.0
|
4.00 units on a scale
Interval 1.0 to 7.5
|
Adverse Events
Subjects Receiving Xyzal
Subjects Receiving Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects Receiving Xyzal
n=20 participants at risk
|
Subjects Receiving Placebo
n=20 participants at risk
|
|---|---|---|
|
General disorders
pruritus - worsening
|
10.0%
2/20 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Immune system disorders
seasonal allergies - worsening
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
sinus infection
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
General disorders
headache
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place