Trial Outcomes & Findings for Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis (NCT NCT00769184)
NCT ID: NCT00769184
Last Updated: 2015-08-19
Results Overview
Those patients that have reached a PGA score of zero \[PGA scale: clear (0) - very severe (5)\], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Weeks 2, 6, & 12.
Results posted on
2015-08-19
Participant Flow
Participant milestones
| Measure |
Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)
Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7).
On left side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks
On right side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks
|
Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)
Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8).
On right side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks
On left side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks
|
|---|---|---|
|
Corticosteroid + LCD/ +Placebo (2 Weeks)
STARTED
|
7
|
8
|
|
Corticosteroid + LCD/ +Placebo (2 Weeks)
COMPLETED
|
6
|
7
|
|
Corticosteroid + LCD/ +Placebo (2 Weeks)
NOT COMPLETED
|
1
|
1
|
|
+LCD / +Placebo Only (4 Weeks)
STARTED
|
6
|
7
|
|
+LCD / +Placebo Only (4 Weeks)
COMPLETED
|
6
|
7
|
|
+LCD / +Placebo Only (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
No Treatment (6 Weeks)
STARTED
|
6
|
7
|
|
No Treatment (6 Weeks)
COMPLETED
|
5
|
6
|
|
No Treatment (6 Weeks)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)
Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7).
On left side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks
On right side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks
|
Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)
Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8).
On right side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks
On left side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks
|
|---|---|---|
|
Corticosteroid + LCD/ +Placebo (2 Weeks)
Adverse Event
|
1
|
0
|
|
Corticosteroid + LCD/ +Placebo (2 Weeks)
Lost to Follow-up
|
0
|
1
|
|
No Treatment (6 Weeks)
Adverse Event
|
1
|
1
|
Baseline Characteristics
Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Corticosteroid+LCD vs Corticosteroid+Placebo
n=15 Participants
one side of body: corticosteroid and liquor carbonis distillate (LCD) treatment applied twice a day, for 2 weeks, then LCD-only twice a day, for 4 weeks, then no treatment for 6 weeks
opposite side of body: corticosteroid and placebo vehicle solution twice a day, for 2 weeks, then placebo vehicle solution-only twice a day, for 4 weeks, then no treatment for 6 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weeks 2, 6, & 12.Population: All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.
Those patients that have reached a PGA score of zero \[PGA scale: clear (0) - very severe (5)\], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.
Outcome measures
| Measure |
Corticosteroid + LCD
n=15 Participants
Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
|
Corticosteroid + Placebo
n=15 Participants
Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
|
|---|---|---|
|
Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.
Percentage with PGA scores ≤ 1 at Week 2
|
33.3 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.
Percentage with PGA scores ≤ 1 at Week 6
|
46.2 percentage of participants
|
15.4 percentage of participants
|
|
Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.
Percentage with PGA scores ≤ 1 at Week 12
|
25.0 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 6, & 12Population: All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.
Mean percent improvement in disease severity using Physician Global Assessment (PGA) \[PGA scale: Clear (0) - Very Severe (5)\] and overall severity scores of target lesions (OTLS) \[OTLS scale None (0) - Very Severe (4)\] based on erythema, scaling and induration, at each visit interval.
Outcome measures
| Measure |
Corticosteroid + LCD
n=15 Participants
Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
|
Corticosteroid + Placebo
n=15 Participants
Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
|
|---|---|---|
|
Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Percent improvement of OTLS score at Week 6
|
46 Mean Percent Improvement
Interval 38.0 to 68.0
|
20 Mean Percent Improvement
Interval 19.0 to 42.0
|
|
Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Percent improvement of OTLS score at Week 2
|
43 Mean Percent Improvement
Interval 31.0 to 59.0
|
43 Mean Percent Improvement
Interval 32.0 to 65.0
|
|
Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Percent improvement of PGA score at Week 2
|
39 Mean Percent Improvement
Interval 26.0 to 58.0
|
34 Mean Percent Improvement
Interval 25.0 to 47.0
|
|
Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Percent improvement of PGA score at Week 6
|
47 Mean Percent Improvement
Interval 34.0 to 72.0
|
25 Mean Percent Improvement
Interval 10.0 to 54.0
|
|
Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Percent improvement of PGA score at Week 12
|
31 Mean Percent Improvement
Interval 14.0 to 61.0
|
12 Mean Percent Improvement
Interval -6.0 to 42.0
|
|
Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Percent improvement of OTLS score at Week 12
|
29 Mean Percent Improvement
Interval 14.0 to 56.0
|
7 Mean Percent Improvement
Interval 4.0 to 35.0
|
Adverse Events
Corticosteroid + LCD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Corticosteroid + Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Corticosteroid + LCD
n=15 participants at risk
Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
|
Corticosteroid + Placebo
n=15 participants at risk
Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
6.7%
1/15 • Number of events 1 • Adverse event information was monitored throughout the entire 12 week study.
|
0.00%
0/15 • Adverse event information was monitored throughout the entire 12 week study.
|
|
Skin and subcutaneous tissue disorders
Bilateral Worsening of Plaque Psoriasis
|
6.7%
1/15 • Number of events 1 • Adverse event information was monitored throughout the entire 12 week study.
|
6.7%
1/15 • Number of events 1 • Adverse event information was monitored throughout the entire 12 week study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place