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NCT00986856
A Phase IV Study Comparing Clinical and Bacteriological Efficacy of Fucidin® Cream With Fucidin® Cream Vehicle in the Treatment of Impetigo in Paediatric Patients
Phase 4 trial testing Fucidin® cream in Impetigo in 58 participants. Terminated before completion.
1 March 2005
Quick facts
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 1 May 2004 |
| Primary completion | 1 March 2005 |
| Estimated completion | 1 March 2005 |
| Sites | 2 locations across Norway, Sweden |
Drugs / interventions tested
- Fucidin® cream — full drug profile →
Conditions studied
- Impetigo — all drugs for Impetigo →
Sponsor
LEO Pharma — full company profile →
Who can join
Adults 2 to 11, any sex, with Impetigo. 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.
-
Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).
Time frame: EOT: Visit at Day 25
Sponsor's own description
To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients. To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream. To investigate the genetic relationship between S. aureus-strains isolated from impetigo patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Interventions for impetigo.
Koning S, van der Sande R, Verhagen AP, van Suijlekom-Smit LW, et al · · 2012 · cited 59× · PMID 22258953 · DOI 10.1002/14651858.cd003261.pub3
Verify or expand the search:
- PubMed search for NCT00986856
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fucidin® cream
Trials testing the same drug.
- NCT03395132 — Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betametha · Phase 3 · terminated
Other LEO Pharma trials
Trials by the same sponsor.
- NCT07335588 — A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus · Phase 3 · not yet recruiting
- NCT07013201 — A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to · Phase 2 · recruiting
- NCT06444867 — A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 15896 · Phase 1 · completed
- NCT06311682 — A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and · Phase 3 · recruiting
- NCT05923099 — A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic De · Phase 2 · 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 NCT00986856 (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 LEO Pharma
- Last refreshed: 21 February 2025
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/NCT00986856.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing