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NCT05585398
A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
Phase 1 trial testing IncobotulinumtoxinA in N/A, as no Specific Medical Condition Will be Treated in 40 participants. Completed in 13 April 2023.
24 February 2023
Quick facts
| Lead sponsor | Merz Pharmaceuticals GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 19 October 2022 |
| Primary completion | 24 February 2023 |
| Estimated completion | 13 April 2023 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- IncobotulinumtoxinA (INCOBOTULINUMTOXINA) — full drug profile →
Conditions studied
- N/A, as no Specific Medical Condition Will be Treated — all drugs for N/A, as no Specific Medical Condition Will be Treated →
Sponsor
Merz Pharmaceuticals GmbH — full company profile →
Who can join
Adults 18 to 45, any sex, with N/A, as no Specific Medical Condition Will be Treated. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the distribution of IncobotulinumtoxinA (Xeomin) in healthy subjects at different volumes, concentrations and doses when administered intradermally and subcutaneously using different delivery methods (conventional needle and microneedles).
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 NCT05585398
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IncobotulinumtoxinA
Trials testing the same drug.
- NCT06604832 — Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture · Phase 1 · completed
- NCT06091020 — A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participant · Phase 2 · completed
- NCT05222607 — Longitudinal Evaluation and Real-world Evidence of NT201 · terminated
- NCT04290169 — Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients · NA · unknown
- NCT03044080 — Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot · Phase 4 · completed
Other Merz Pharmaceuticals GmbH trials
Trials by the same sponsor.
- NCT04766723 — A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Ad · Phase 2 · completed
- NCT03986424 — Local Study of Akatinol Memantine in VaD in Russia · Phase 3 · completed
- NCT03256942 — Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augm · NA · completed
- NCT04210258 — Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face · completed
- NCT02270736 — Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troubles · Phase 3 · 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 NCT05585398 (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 Merz Pharmaceuticals GmbH
- Last refreshed: 22 June 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/NCT05585398.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing