A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01005823
First received: October 23, 2009
Last updated: October 21, 2013
Last verified: December 2010
  Purpose

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.


Condition Intervention Phase
Atopic Dermatitis
Drug: LEO 29102 cream
Drug: LEO 29102 placebo cream
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Adverse events, laboratory testing, ECG, vital signs [ Time Frame: Day 9 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the efficacy of LEO 29102 cream in the treatment of AD [ Time Frame: Day 9 ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LEO 29102 cream 0.3 mg/g Drug: LEO 29102 cream
Twice daily application for 7 days
Active Comparator: LEO 29102 cream 1.0 mg/g Drug: LEO 29102 cream
Twice daily application for 7 days
Active Comparator: LEO 29102 cream 2.5 mg/g Drug: LEO 29102 cream
Twice daily application for 7 days
Placebo Comparator: LEO 29102 placebo cream Drug: LEO 29102 placebo cream
LEO 29102 placebo cream

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-55 years
  • Atopic dermatitis of 850-1700cm2
  • In good health

Criteria for exclusion:

  • Co-morbid conditions
  • Hepatic dysfunction
  • Clinical infection
  • Immunocompromised status
  • Clinically significant illness
  • Use of immunomodulating treatment
  • Medications related to respiratory system or to heart rhythm
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005823

Locations
Netherlands
PRA International, University Medical Centre
Groningen, Netherlands
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Kahlid Aboufarha PRA International
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01005823     History of Changes
Other Study ID Numbers: LEO 29102-C03, EudraCT No. 2009-014303-30
Study First Received: October 23, 2009
Last Updated: October 21, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on July 26, 2014