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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow for 3 periods

Period 1:   Corticosteroid + LCD/ +Placebo (2 Weeks)
    Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)   Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)
STARTED   7   8 
COMPLETED   6   7 
NOT COMPLETED   1   1 
Adverse Event                1                0 
Lost to Follow-up                0                1 

Period 2:   +LCD / +Placebo Only (4 Weeks)
    Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)   Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)
STARTED   6   7 
COMPLETED   6   7 
NOT COMPLETED   0   0 

Period 3:   No Treatment (6 Weeks)
    Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)   Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)
STARTED   6   7 
COMPLETED   5   6 
NOT COMPLETED   1   1 
Adverse Event                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Corticosteroid+LCD vs Corticosteroid+Placebo

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


Baseline Measures
   Corticosteroid+LCD vs Corticosteroid+Placebo 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   2 
Gender 
[Units: Participants]
 
Female   5 
Male   10 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   13 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.   [ Time Frame: Weeks 2, 6, & 12. ]

2.  Secondary:   Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions   [ Time Frame: Weeks 2, 6, & 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: bgreen@neostrata.com



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