NCT00519675

Brief Summary

The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
2 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

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

First QC Date

August 22, 2007

Last Update Submit

May 9, 2023

Conditions

Eczema

Keywords

Chronic hand eczemaChronic hand dermatitisPatients with chronic hand eczema, who are refractory to topical corticosteroids

Outcome Measures

Primary Outcomes (1)

  • Safety assessments

Secondary Outcomes (1)

  • Efficacy (Physicians Global Assessment)

Interventions

alitretinoinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous participation in therapeutic trials involving chronic hand eczema
  • Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score

You may not qualify if:

  • Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Paris, France

Location

Unknown Facility

Saint-Etienne, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Dresden, Germany

Location

MeSH Terms

Conditions

Eczema

Interventions

Alitretinoin

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

TretinoinVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Jürgen Maares, MD

    Basilea Pharmaceutica

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

May 1, 2007

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

FR(2)DE(2)