A Safety, Tolerability and Pharmacokinetic Study of LEO 2... | NCT01005823

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

NCT01005823

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Atopic Dermatitis

Interventions

LEO 29102 cream
LEO 29102 placebo cream

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT No. 2009-014303-30

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Oct 23, 2009

First Submission Date that Met QC Criteria

Oct 30, 2009

First Posted Date

Nov 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
LEO 29102 cream 0.3 mg/g	Active Comparator	Drug: LEO 29102 cream
LEO 29102 cream 1.0 mg/g	Active Comparator	Drug: LEO 29102 cream
LEO 29102 cream 2.5 mg/g	Active Comparator	Drug: LEO 29102 cream
LEO 29102 placebo cream	Placebo Comparator	Drug: LEO 29102 placebo cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LEO 29102 cream	Drug	Twice daily application for 7 days	LEO 29102 cream 0.3 mg/g LEO 29102 cream 1.0 mg/g LEO 29102 cream 2.5 mg/g

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events, laboratory testing, ECG, vital signs		Day 9

Secondary Outcomes

Measure	Description	Time Frame
To assess the efficacy of LEO 29102 cream in the treatment of AD		Day 9

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kahlid Aboufarha	PRA Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRA International, University Medical Centre		Groningen			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided