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LEO 29102 Single and Multiple Dose Study by Dermal Application

This study has been completed.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00891709
First received: April 30, 2009
Last updated: January 29, 2010
Last verified: January 2010

April 30, 2009
January 29, 2010
March 2009
June 2009   (final data collection date for primary outcome measure)
To determine the safety and tolerability [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00891709 on ClinicalTrials.gov Archive Site
To determine the pharmacokinetics [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
LEO 29102 Single and Multiple Dose Study by Dermal Application
A Phase 1, First in Man, Safety, Tolerability and Pharmacokinetic Study of Single Ascending and Multiple Cutaneous Doses of LEO 29102 2.5 mg/g Cream or LEO 29102 Cream Vehicle in Healthy Male Subjects

The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy male subjects.

The study is divided into one single dose part followed by a multiple dose part.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Atopic Dermatitis
Drug: LEO 29102
First-in-man. Healthy volunteers
  • Experimental: 1
    LEO 29102 2.5 mg/g cream
    Intervention: Drug: LEO 29102
  • Placebo Comparator: 2
    LEO 29102 cream vehicle
    Intervention: Drug: LEO 29102
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male adults between the age of 18 and 55 years (both inclusive) and with a BMI between 19 and 30 kg/m2 (both inclusive).
  • Subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ECG), blood pressuer and heart rate, and clinical laboratory evaluation.

Exclusion Criteria:

  • Subjects who show signs of eczema or other skin lesions.
  • Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00891709
LEO 29102-C01
No
Pontus Hegardt, Clinical Trial Manager, LEO Pharma A/S
LEO Pharma
Not Provided
Principal Investigator: Anthony Priestley, MBChB MFPM LCG Bioscience, Bourn Hall, Bourn, Cambridgeshire, CB23 2TN, UK
LEO Pharma
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP