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
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 April 16, 2014