Last reviewed · How we verify

NCT00124436

Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

Completed Phase 3 Last updated 9 May 2023
What this trial tests

Phase 3 trial testing alitretinoin in Hand Dermatoses in 300 participants. Completed in 1 February 2007.

Timeline
1 March 2005
Primary endpoint
1 January 2007
1 February 2007

Quick facts

Lead sponsorBasilea Pharmaceutica
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment300
Start date1 March 2005
Primary completion1 January 2007
Estimated completion1 February 2007
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

Adults 18 to 75, any sex, with Hand Dermatoses. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interventions for hand eczema.
    Christoffers WA, Coenraads PJ, Svensson Å, Diepgen TL, et al · · 2019 · cited 37× · PMID 31025714 · DOI 10.1002/14651858.cd004055.pub2
  2. Use of Longitudinal Dose-Response Modeling to Support the Efficacy and Tolerability of Alitretinoin in Severe Refractory Chronic Hand Eczema (CHE).
    Schmith GD, Singh R, Gomeni R, Graff O, et al · · 2015 · cited 4× · PMID 26225249 · DOI 10.1002/psp4.24

Verify or expand the search:

Other trials of alitretinoin

Trials testing the same drug.

Other Basilea Pharmaceutica trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00124436.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing