A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
NCT ID: NCT01005823
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2009-10-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LEO 29102 cream 0.3 mg/g
LEO 29102 cream
Twice daily application for 7 days
LEO 29102 cream 1.0 mg/g
LEO 29102 cream
Twice daily application for 7 days
LEO 29102 cream 2.5 mg/g
LEO 29102 cream
Twice daily application for 7 days
LEO 29102 placebo cream
LEO 29102 placebo cream
LEO 29102 placebo cream
Interventions
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LEO 29102 cream
Twice daily application for 7 days
LEO 29102 placebo cream
LEO 29102 placebo cream
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Kahlid Aboufarha
Role: PRINCIPAL_INVESTIGATOR
PRA Health Sciences
Locations
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PRA International, University Medical Centre
Groningen, , Netherlands
Countries
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Other Identifiers
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EudraCT No. 2009-014303-30
Identifier Type: -
Identifier Source: secondary_id
LEO 29102-C03
Identifier Type: -
Identifier Source: org_study_id
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