NCT00124475 is a Phase 3 clinical trial of alitretinoin in Hand Dermatoses, sponsored by Basilea Pharmaceutica.

Who is sponsoring NCT00124475?

NCT00124475 is sponsored by Basilea Pharmaceutica.

What drugs are being tested in NCT00124475?

Interventions in NCT00124475: alitretinoin.

What condition does NCT00124475 study?

NCT00124475 studies Hand Dermatoses.

Is NCT00124475 still recruiting?

NCT00124475 is currently completed. Last updated 9 May 2023.

Last reviewed 2023-05-09 · How we verify

NCT00124475

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis

Completed Phase 3 Last updated 9 May 2023

What this trial tests

Phase 3 trial testing alitretinoin in Hand Dermatoses in 1,035 participants. Completed in 1 September 2007.

Timeline

1 December 2004

Primary endpoint
1 October 2006

1 September 2007

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,035
Start date	1 December 2004
Primary completion	1 October 2006
Estimated completion	1 September 2007
Sites	1 location across Germany

Drugs / interventions tested

alitretinoin (ALITRETINOIN) — full drug profile →

Conditions studied

Hand Dermatoses — all drugs for Hand Dermatoses →

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.

Physicians global assessment
at week 12 or 24

Sponsor's own description

The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Publications & conference data

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

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
Cost-effectiveness of oral alitretinoin in patients with severe chronic hand eczema--a long-term analysis from a Swiss perspective.
Blank PR, Blank AA, Szucs TD. · · 2010 · cited 13× · PMID 20579358 · DOI 10.1186/1471-5945-10-4
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.

NCT01245140 — Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis · Phase 2 · completed
NCT00817063 — Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema · Phase 3 · completed

Other Basilea Pharmaceutica trials

Trials by the same sponsor.

NCT06961708 — A Study of Fosmanogepix in Healthy Adult Chinese Subjects · Phase 1 · completed
NCT06808646 — A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin · Phase 1 · completed
NCT06733675 — Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination · Phase 1 · recruiting
NCT05421858 — A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invas · Phase 3 · recruiting
NCT06665555 — Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00124475 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 9 May 2023

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/NCT00124475.

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