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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: LEO 29102 placebo cream; Drug: LEO 29102 cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005823

EudraCT No. 2009-014303-30

LEO 29102-C03

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

LEO 29102 cream 0.3 mg/g

Active Comparator group

Treatment:

Drug: LEO 29102 cream

LEO 29102 cream 1.0 mg/g

Active Comparator group

Treatment:

Drug: LEO 29102 cream

LEO 29102 cream 2.5 mg/g

Active Comparator group

Treatment:

Drug: LEO 29102 cream

LEO 29102 placebo cream

Placebo Comparator group

Treatment:

Drug: LEO 29102 placebo cream