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Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00769184
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
NeoStrata Company, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Corticosteroid
Other: Placebo
Drug: LCD
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right) Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)
Hide Arm/Group Description

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 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

Period Title: Corticosteroid + LCD/ +Placebo (2 Weeks)
Started 7 8
Completed 6 7
Not Completed 1 1
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             0             1
Period Title: +LCD / +Placebo Only (4 Weeks)
Started 6 7
Completed 6 7
Not Completed 0 0
Period Title: No Treatment (6 Weeks)
Started 6 7
Completed 5 6
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Arm/Group Title Corticosteroid+LCD vs Corticosteroid+Placebo
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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

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Fifteen patients with localized chronic plaque psoriasis (less than or equal to 6% BSA and PGA score greater than or equal to 3) were enrolled. Eleven patients completed the study. Three patients were removed due to an adverse event, and 1 patient was lost to follow-up after week 2.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  86.7%
>=65 years
2
  13.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  13.3%
White
13
  86.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.
Hide Description 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.
Time Frame Weeks 2, 6, & 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.
Arm/Group Title Corticosteroid + LCD Corticosteroid + Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: percentage of participants
Percentage with PGA scores ≤ 1 at Week 2 33.3 6.7
Percentage with PGA scores ≤ 1 at Week 6 46.2 15.4
Percentage with PGA scores ≤ 1 at Week 12 25.0 16.7
2.Secondary Outcome
Title Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Time Frame Weeks 2, 6, & 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.
Arm/Group Title Corticosteroid + LCD Corticosteroid + Placebo
Hide Arm/Group Description:
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 solution 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.
Overall Number of Participants Analyzed 15 15
Mean (Full Range)
Unit of Measure: Mean Percent Improvement
Percent improvement of PGA score at Week 2
39
(26 to 58)
34
(25 to 47)
Percent improvement of PGA score at Week 6
47
(34 to 72)
25
(10 to 54)
Percent improvement of PGA score at Week 12
31
(14 to 61)
12
(-6 to 42)
Percent improvement of OTLS score at Week 2
43
(31 to 59)
43
(32 to 65)
Percent improvement of OTLS score at Week 6
46
(38 to 68)
20
(19 to 42)
Percent improvement of OTLS score at Week 12
29
(14 to 56)
7
(4 to 35)
Time Frame Adverse event information was monitored throughout the entire 12 week study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Corticosteroid + LCD Corticosteroid + Placebo
Hide Arm/Group Description 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 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.
All-Cause Mortality
Corticosteroid + LCD Corticosteroid + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Corticosteroid + LCD Corticosteroid + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Corticosteroid + LCD Corticosteroid + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/15 (13.33%)      1/15 (6.67%)    
Skin and subcutaneous tissue disorders     
Contact Dermatitis  [1]  1/15 (6.67%)  1 0/15 (0.00%)  0
Bilateral Worsening of Plaque Psoriasis  [2]  1/15 (6.67%)  1 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
One subject was removed from the study due to a treatment-related adverse event involving contact dermatitis with clobetasol, LCD, and vehicle with bilateral itching.
[2]
Two subjects were removed from the study due to treatment-related bilateral worsening of their psoriasis.
This was a bilateral study in which 15 subjects total were recruited and randomized to receive both interventions simultaneously by dividing treatment arms to each side of the body.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Barbara Green, RPH, MS
Organization: NeoStrata Co., Inc.
Phone: (609) 520-0715
Responsible Party: NeoStrata Company, Inc.
ClinicalTrials.gov Identifier: NCT00769184     History of Changes
Other Study ID Numbers: 08-LCDSTRD
First Submitted: October 7, 2008
First Posted: October 9, 2008
Results First Submitted: November 14, 2014
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015