NCT00124436

Brief Summary

Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to \>75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2005

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

March 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

July 26, 2005

Last Update Submit

May 9, 2023

Conditions

Hand Dermatoses

Keywords

Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed

Outcome Measures

Primary Outcomes (1)

  • Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24

Secondary Outcomes (5)

  • Patient's global assessment

  • Extent of disease

  • Time to respond

  • Modified total lesion symptom score

  • at week 12 or 24

Interventions

alitretinoinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous participation in protocol BAP089
  • Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease

You may not qualify if:

  • Female patients who are pregnant or who want to become pregnant
  • Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Ruzicka

Düsseldorf, 40225, Germany

Location

Related Publications (1)

  • Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.

    PMID: 15611422BACKGROUND

MeSH Terms

Conditions

Hand Dermatoses

Interventions

Alitretinoin

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Thomas Ruzicka, MD

    University of Düsseldorf, Dermatological Hospital, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

March 1, 2005

Primary Completion

January 1, 2007

Study Completion

February 1, 2007

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

DE(1)