A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01580488
First received: April 16, 2012
Last updated: November 8, 2013
Last verified: November 2013
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator)
Condition: Psoriasis Vulgaris
Interventions: Drug: B LEO 35299 20 mg/g cream
Drug: C LEO 35299 20 mg/g cream
Drug: E LEO 35299 10 mg/g solution
Drug: F LEO 35299 10 mg/g solution
Drug: Daivonex® ointment
Drug: Daivonex® ointment vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject first visit, start date: 24-Apr-2012 Last subject last visit, completion date: 05-Jun-2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomisation, the subjects entered a washout phase of up to 21 days (if required) where antipsoriatic treatment and other relevant medications or treatments had to be discontinued as defined by the exclusion criteria

Reporting Groups
  Description
All Study Participants Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation "B" containing 20 mg/g LEO 35299 Topical cream formulation "C" containing 20 mg/g LEO 35299 Topical solution formulation "E" containing 10 mg/g LEO 35299 Topical solution formulation "F" containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle

Participant Flow:   Overall Study
    All Study Participants  
STARTED     24  
COMPLETED     23  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
All Study Participants No text entered.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 11.1  
Gender  
[units: participants]
 
Female     5  
Male     19  
Region of Enrollment  
[units: participants]
 
France     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Total Clinical Score From Baseline to Day 22   [ Time Frame: Baseline to Day 22 ]

2.  Secondary:   Change in Erythema From Baseline to Day 22   [ Time Frame: Baseline to Day 22 ]

3.  Secondary:   Change in Infiltration From Baseline to Day 22   [ Time Frame: Baseline to Day 22 ]

4.  Secondary:   Change in Scaling From Baseline to Day 22   [ Time Frame: Baseline to Day 22 ]

5.  Secondary:   Change in Lesion Thickness From Baseline to Day 22   [ Time Frame: Baseline to Day 22 ]

6.  Secondary:   Change in Skin Thickness From Baseline to Day 22   [ Time Frame: Baseline to Day 22 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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 an exploratory study in which each of the 24 subjects received all 6 treatments on 2 cm diameter dermal test sites. Regarding Adverse Events, only local dermal reactions could be potentially attributed to a specific treatment.  


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Manager
Organization: LEO Pharma A/S
phone: +45 4494 5888
e-mail: ctr.disclosure@leo-pharma.com


No publications provided


Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01580488     History of Changes
Other Study ID Numbers: PLQ-008, 2011-005349-11
Study First Received: April 16, 2012
Results First Received: August 19, 2013
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)