LEO 29102 Single and Multiple Dose Study by Dermal Application

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: LEO 29102

• Registration Number: NCT00891709
• Lead Sponsor: LEO Pharma

Brief Summary

The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy male subjects.

The study is divided into one single dose part followed by a multiple dose part.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-01
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Male adults between the age of 18 and 55 years (both inclusive) and with a BMI between 19 and 30 kg/m2 (both inclusive).
• Subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ECG), blood pressuer and heart rate, and clinical laboratory evaluation.

Exclusion Criteria

• Subjects who show signs of eczema or other skin lesions.
• Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	LEO 29102	LEO 29102 2.5 mg/g cream
2	LEO 29102	LEO 29102 cream vehicle

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics

Trial Locations

Locations (1)

LCG Bioscience; 🇬🇧 Bourn, Cambridgeshire, United Kingdom