LEO 29102 Single and Multiple Dose Study by Dermal Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00891709
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : March 3, 2016
Information provided by (Responsible Party):
LEO Pharma

April 30, 2009
May 1, 2009
March 3, 2016
March 2009
June 2009   (Final data collection date for primary outcome measure)
To determine the safety and tolerability
Same as current
Complete list of historical versions of study NCT00891709 on Archive Site
To determine the pharmacokinetics
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
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Identifier (NCT Number) in Medline.
Same as current
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).
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
LEO 29102-C01
Not Provided
Not Provided
LEO Pharma
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