Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream

LEO Pharma

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: cream vehicle

Drug: LEO 39652 cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT01850849

LP0083-1011

Details and patient eligibility

About

The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.

Enrollment

23 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects or subjects with AD as defined by the Hanifen and Rajka criteria and with at least mild disease activity (IGA >2) for the whole body
AD lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for AD subjects)
Male subjects aged between 18 and 65 years with a body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive

Exclusion criteria

Subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects)
Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion.
Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
History of or current cardiac arrhythmic disorder
Subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer.
Subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the Investigator