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NCT02824926
Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis
Phase 2 trial testing Dapaconazole in Tinea Pedis in 60 participants. Completed in 1 January 2015.
1 December 2014
Quick facts
| Lead sponsor | Gilberto De Nucci |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 July 2014 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 January 2015 |
Drugs / interventions tested
- Dapaconazole — full drug profile →
- Ketoconazole (ketoconazole) — full drug profile →
Conditions studied
- Tinea Pedis — all drugs for Tinea Pedis →
Sponsor
Gilberto De Nucci
Who can join
Adults 18 to 60, any sex, with Tinea Pedis. 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.
-
Clinical cure of the lesion(s)
Time frame: 14 days
Assessment of presence or absence of lesion(s) by clinical examination -
Mycological cure of the lesion(s)
Time frame: 14 days
Laboratory test for presence or absence of Tinea Pedis
Sponsor's own description
This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.
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 NCT02824926
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dapaconazole
Trials testing the same drug.
- NCT03320486 — Non-inferiority Trial of Dapaconazole Versus Ketoconazole · Phase 3 · completed
- NCT03359070 — Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris · Phase 2 · completed
Other recruiting trials for Tinea Pedis
Currently open trials in the same condition.
- NCT07056660 — Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis · NA · recruiting
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 NCT02824926 (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 Gilberto De Nucci
- Last refreshed: 3 July 2016
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/NCT02824926.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing