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NCT00124436
Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment
Phase 3 trial testing alitretinoin in Hand Dermatoses in 300 participants. Completed in 1 February 2007.
1 January 2007
Quick facts
| Lead sponsor | Basilea Pharmaceutica |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 300 |
| Start date | 1 March 2005 |
| Primary completion | 1 January 2007 |
| Estimated completion | 1 February 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.
- Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24
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):
-
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 -
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:
- PubMed search for NCT00124436
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT00124436 (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/NCT00124436.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing