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LEO 29102 Single and Multiple Dose Study by Dermal Application

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891709
First Posted: May 1, 2009
Last Update Posted: March 3, 2016
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.
Information provided by (Responsible Party):
LEO Pharma
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis Drug: LEO 29102 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • To determine the safety and tolerability

Secondary Outcome Measures:
  • To determine the pharmacokinetics

Enrollment: 64
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
LEO 29102 2.5 mg/g cream
Drug: LEO 29102
First-in-man. Healthy volunteers
Placebo Comparator: 2
LEO 29102 cream vehicle
Drug: LEO 29102
First-in-man. Healthy volunteers

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891709


Locations
United Kingdom
LCG Bioscience
Bourn, Cambridgeshire, United Kingdom, CB23 2TN
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Anthony Priestley, MBChB MFPM LCG Bioscience, Bourn Hall, Bourn, Cambridgeshire, CB23 2TN, UK
  More Information

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00891709     History of Changes
Other Study ID Numbers: LEO 29102-C01
First Submitted: April 30, 2009
First Posted: May 1, 2009
Last Update Posted: March 3, 2016
Last Verified: January 2010

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases