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

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: LEO 29102 cream; Drug: LEO 29102 placebo cream

• Registration Number: NCT01005823
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-12
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 29102 cream 0.3 mg/g	LEO 29102 cream	-
LEO 29102 cream 2.5 mg/g	LEO 29102 cream	-
LEO 29102 placebo cream	LEO 29102 placebo cream	-
LEO 29102 cream 1.0 mg/g	LEO 29102 cream	-

Primary Outcome Measures

Name	Time	Method
Adverse events, laboratory testing, ECG, vital signs	Day 9

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of LEO 29102 cream in the treatment of AD	Day 9

Trial Locations

Locations (1)

PRA International, University Medical Centre; 🇳🇱 Groningen, Netherlands