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NCT00309621
Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
Phase 3 trial testing alitretinoin in Hand Dermatoses in 250 participants. Completed in 1 May 2007.
1 April 2007
Quick facts
| Lead sponsor | Basilea Pharmaceutica |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 1 April 2006 |
| Primary completion | 1 April 2007 |
| Estimated completion | 1 May 2007 |
| Sites | 33 locations across Canada, Germany, Poland |
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.
- Safety:
- Adverse Events
- Safety Laboratory
- Radiological investigations (bone density, x-ray)
Sponsor's own description
Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00309621
- 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 NCT00309621 (US National Library of Medicine, public domain)
- 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/NCT00309621.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing