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

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ClinicalTrials.gov Identifier: NCT01005823
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : October 22, 2013
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Atopic Dermatitis Drug: LEO 29102 cream Drug: LEO 29102 placebo cream Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
Study Start Date : October 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Adverse events, laboratory testing, ECG, vital signs [ Time Frame: Day 9 ]

Secondary Outcome Measures :
  1. To assess the efficacy of LEO 29102 cream in the treatment of AD [ Time Frame: Day 9 ]


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:   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

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): NCT01005823


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

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01005823     History of Changes
Other Study ID Numbers: LEO 29102-C03
EudraCT No. 2009-014303-30
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: December 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