A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis
February 21, 2025 updated by: LEO Pharma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands
- PRA International, University Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: LEO 29102 cream 0.3 mg/g
|
Twice daily application for 7 days
|
|
Active Comparator: LEO 29102 cream 1.0 mg/g
|
Twice daily application for 7 days
|
|
Active Comparator: LEO 29102 cream 2.5 mg/g
|
Twice daily application for 7 days
|
|
Placebo Comparator: LEO 29102 placebo cream
|
LEO 29102 placebo cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse events, laboratory testing, ECG, vital signs
Time Frame: Day 9
|
Day 9
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess the efficacy of LEO 29102 cream in the treatment of AD
Time Frame: Day 9
|
Day 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kahlid Aboufarha, PRA Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 23, 2009
First Submitted That Met QC Criteria
October 30, 2009
First Posted (Estimated)
November 1, 2009
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 21, 2025
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEO 29102-C03
- EudraCT No. 2009-014303-30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.