LEO 29102 Single and Multiple Dose Study by Dermal Application

Atopic Dermatitis Clinical Trial

Official title:

A Phase 1, First in Man, Safety, Tolerability and Pharmacokinetic Study of Single Ascending and Multiple Cutaneous Doses of LEO 29102 2.5 mg/g Cream or LEO 29102 Cream Vehicle in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891709
• Other study ID #: LEO 29102-C01
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2009
• Last updated: March 2, 2016
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LEO 29102
First-in-man. Healthy volunteers

Locations

Country	Name	City	State
United Kingdom	LCG Bioscience	Bourn	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability			Yes
Secondary	To determine the pharmacokinetics			No