NCT01005823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 24, 2025

Status Verified

December 1, 2010

Enrollment Period

7 months

First QC Date

October 23, 2009

Last Update Submit

February 21, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events, laboratory testing, ECG, vital signs

    Day 9

Secondary Outcomes (1)

  • To assess the efficacy of LEO 29102 cream in the treatment of AD

    Day 9

Study Arms (4)

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

LEO 29102 creamDRUG

Twice daily application for 7 days

LEO 29102 cream 0.3 mg/gLEO 29102 cream 1.0 mg/gLEO 29102 cream 2.5 mg/g
LEO 29102 placebo creamDRUG

LEO 29102 placebo cream

LEO 29102 placebo cream

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55 years
  • Atopic dermatitis of 850-1700cm2
  • In good health

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA International, University Medical Centre

Groningen, Netherlands

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Kahlid Aboufarha

    PRA Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2009

First Posted

November 2, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 24, 2025

Record last verified: 2010-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)