LEO 29102 Single and Multiple Dose Study by Dermal Application

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: LEO 29102

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891709

LEO 29102-C01

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

LEO 29102 2.5 mg/g cream

Treatment:

Drug: LEO 29102

2

Placebo Comparator group

Description:

LEO 29102 cream vehicle

Treatment:

Drug: LEO 29102