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Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102

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ClinicalTrials.gov Identifier: NCT01423656
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:

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 subjects.

The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LEO 29102 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : August 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: LEO 29102 Drug: LEO 29102
Placebo Comparator: LEO 29102 vehicle Drug: Placebo
Placebo Comparator: LEO 29102 vehicle

Primary Outcome Measures :
  1. Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,clinical laboratory and local tolerability assessments [ Time Frame: 7 days after last dosing ]

Secondary Outcome Measures :
  1. LEO 29102 and metabolites in blood and urine [ Time Frame: 72 hours after dosing ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subjects will be Caucasian males and females between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
  • Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations

Exclusion Criteria:

  • Subjects who suffer from, or show signs of eczema or other skin lesions.
  • Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion.
  • Subjects with a significant history of drug allergy as determined by the Investigator.
  • Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.

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): NCT01423656

United Kingdom
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
LEO Pharma
Principal Investigator: Ashley Brooks, MBChB Covance

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01423656     History of Changes
Other Study ID Numbers: LEO 29102-C06
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

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