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

NCT ID: NCT01005823

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LEO 29102 cream 0.3 mg/g

Group Type ACTIVE_COMPARATOR

LEO 29102 cream

Intervention Type DRUG

Twice daily application for 7 days

LEO 29102 cream 1.0 mg/g

Group Type ACTIVE_COMPARATOR

LEO 29102 cream

Intervention Type DRUG

Twice daily application for 7 days

LEO 29102 cream 2.5 mg/g

Group Type ACTIVE_COMPARATOR

LEO 29102 cream

Intervention Type DRUG

Twice daily application for 7 days

LEO 29102 placebo cream

Group Type PLACEBO_COMPARATOR

LEO 29102 placebo cream

Intervention Type DRUG

LEO 29102 placebo cream

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LEO 29102 cream

Twice daily application for 7 days

Intervention Type DRUG

LEO 29102 placebo cream

LEO 29102 placebo cream

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kahlid Aboufarha

Role: PRINCIPAL_INVESTIGATOR

PRA Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PRA International, University Medical Centre

Groningen, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT No. 2009-014303-30

Identifier Type: -

Identifier Source: secondary_id

LEO 29102-C03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.