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

NCT01850849 | Completed Phase 1

• 1 other identifier: LP0083-1011
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments

  Up to 48 hours after dosing

Secondary Outcomes (1)

• LEO 39652 and metabolites in blood

  Up to 48 hours after dosing

Study Arms (2)

LEO 39652 cream

EXPERIMENTAL

Active drug

Drug: LEO 39652 cream

LEO 39652 cream vehicle

PLACEBO COMPARATOR

Placebo drug

Drug: cream vehicle

Interventions

LEO 39652 cream DRUG

LEO 39652 cream

cream vehicle DRUG

LEO 39652 cream vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Covance Clinical Research Unit, Hyde Street, Leeds, UK

Leeds, LS2 9LH, United Kingdom

Location

Covance Royal Liverpool Clinical Research Unit

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Joseph Chiesa, MD

  Covance Clinical Research Unit, Hyde Street, Leeds, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 10, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 24, 2025

Record last verified: 2015-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)