Trial Outcomes & Findings for Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema (NCT NCT00946478)
NCT ID: NCT00946478
Last Updated: 2014-03-10
Results Overview
Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 weeks
Results posted on
2014-03-10
Participant Flow
Participant milestones
| Measure |
Pimecrolimus
Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
|
Vehicle Cream
Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema
Baseline characteristics by cohort
| Measure |
Pimecrolimus
n=20 Participants
Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
|
Vehicle Cream
n=20 Participants
Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksDelta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo
Outcome measures
| Measure |
Pimecrolimus
n=20 Participants
Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
|
Vehicle Cream
n=20 Participants
Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
|
|---|---|---|
|
Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD
|
.0016 delta-delta ct units on PCR
Standard Error .002
|
.0024 delta-delta ct units on PCR
Standard Error .004
|
Adverse Events
Pimecrolimus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle Cream
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place