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NCT05890703: LIDOTETRA
Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream
Phase 2 trial testing IMP2 (lidocaine-23%-tetracaine-7% gel) in Ulcus Cruris in 40 participants. Status unknown.
31 October 2023
Quick facts
| Lead sponsor | Juerg Hafner |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 June 2023 |
| Primary completion | 31 October 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- IMP2 (lidocaine-23%-tetracaine-7% gel) — full drug profile →
- IMP1 (EMLA 5% cream) — full drug profile →
Conditions studied
- Ulcus Cruris — all drugs for Ulcus Cruris →
- Ecthyma — all drugs for Ecthyma →
- Ulcer, Leg — all drugs for Ulcer, Leg →
- Ulcer Venous — all drugs for Ulcer Venous →
Sponsor
Juerg Hafner — full company profile →
Who can join
Adults 18 to 90, any sex, with Ulcus Cruris or Ecthyma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In a single-blind, crossover, randomized, controlled trial with 40 participants we aim to demonstrate superior anaesthetic efficacy of lidocaine-23%-tetracaine-7% (IMP2) gel over EMLA 5% cream (IMP1) at comparable safety in sharp wound debridement of chronic leg ulcers. This is a monocentric investigator initiated trial conducted in the University Hospital Zurich. In this longitudinal trial, participants receive a sequence of different treatments (treatments on different days) and therefore are randomly assigned to one of two treatment sequences. One-half of participants will first receive IMP1 (first treatment visit, randomized) and then IMP2 (second treatment visit, crossover); the other half of participants the reverse sequence (first treatment visit: IMP2, second treatment visit: IMP1). Primary Objective: We want to show that IMP 2 (lidocaine-23%-tetracaine-7% gel) is more effective in pain reduction than IMP 1 (EMLA® 5% cream) in sharp wound debridement.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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 NCT05890703 (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 Juerg Hafner
- Last refreshed: 6 June 2023
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