NCT00392067

Brief Summary

To compare the efficacy and safety of two different dose combinations of LEO19123 (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with atopic dermatitis

Trial Health

90
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
4 countries

4 active sites

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, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 24, 2025

Status Verified

August 1, 2007

First QC Date

October 24, 2006

Last Update Submit

February 21, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Proof of concept

Secondary Outcomes (1)

  • Safety

Interventions

Calcipotriol and LEO80122 (LEO19123 cream)DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka
  • The score of erythema, induration/papulation, excoriation and lichenification, four of the five clinical signs in the Total Severity Score, should at least correspond to moderate involvement, i.e. severity greater than or equal to 2, at Visit 1
  • Treatment area amenable to topical treatment
  • Attending a hospital outpatient clinic or the private practice of a dermatologist
  • Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period
  • Males between 18-50 years

You may not qualify if:

  • Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used)
  • PUVA or UVB therapy within 4 weeks prior to randomisation
  • Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV within 2 weeks prior to randomisation
  • Other topical therapy on the treatment area (except for the use of emollient on the entire body and use of hydrocortisone cream 1% on AD lesions on head and neck) within 1 week prior to randomisation
  • Use of any other kind of treatment (drug, non-drug) for AD during the study except for the use of: - Investigational product on trunk and limbs lesions only during the treatment phase - Hydrocortisone cream 1% on head and neck lesions - Emollient on the entire body
  • Use of anti-histamines during the study
  • Current diagnosis of exfoliative erythrodermia
  • Clinical infection (impetiginised atopic dermatitis) on the treatment area
  • Planned exposure to amount of sun or ultraviolet light during the study that may affect atopic dermatitis
  • Known or suspected hypersensitivity to component(s) of the investigational product
  • Known or suspected severe renal insufficiency or severe hepatic disorders
  • Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
  • Patients with history of cancer including skin cancer
  • Patients with history of an immunocompromised disease (e.g. lymphoma, HIV, Wiskott-Aldrich Syndrome)
  • Current participation in any other interventional clinical trial
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinique Dermatologique Maizerets

Québec, Quebec, G1J 1X7, Canada

Location

Hudklinikken

Nykøbing Falster, 4800, Denmark

Location

Helsinki University Central Hospital

Helsinki, 00250, Finland

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

calcipotriene

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

  • Kristian Thestrup-Pedersen, MD

    Hudklinikken

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 25, 2006

Study Start

October 1, 2006

Study Completion

June 1, 2007

Last Updated

February 24, 2025

Record last verified: 2007-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)CA(1)DK(1)GB(1)