Last reviewed · How we verify
Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Phase 2 trial testing DaxibotulinumtoxinA for injection in Lateral Canthal Lines in 63 participants. Completed in 23 April 2020.
| Lead sponsor | Revance Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 11 March 2019 |
| Primary completion | 23 April 2020 |
| Estimated completion | 23 April 2020 |
| Sites | 4 locations across United States |
Revance Therapeutics, Inc. — full company profile →
Adults 18 to 65, any sex, with Lateral Canthal Lines. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1: DAXI 12 U | 9 | |
| Cohort 2: DAXI 24 U | 10 | |
| Cohort 3: DAXI 36 U | 8 | |
| Cohort 4: DAXI 48 U | 14 |
Time frame: The adverse events were collected throughout the entire study, up to 36 weeks after LCL treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1: DAXI 12 U | Cohort 2: DAXI 24 U | Cohort 3: DAXI 36 U | Cohort 4: DAXI 48 U |
|---|---|---|---|---|---|
| Mastitis | Infections and infestations | — | — | — | — |
| Reaction | System | Cohort 1: DAXI 12 U | Cohort 2: DAXI 24 U | Cohort 3: DAXI 36 U | Cohort 4: DAXI 48 U |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | — | — | — | — |
| Injection site erythema | General disorders | — | — | — | — |
| Injection site oedema | General disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Blepharospasm | Eye disorders | — | — | — | — |
| Eye pruritus | Eye disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Gingival pain | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Injection site pain | General disorders | — | — | — | — |
| Injury associated with device | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Ear infection | Infections and infestations | — | — | — | — |
| Herpes zoster | Infections and infestations | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Localised infection | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Viral upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Muscle strain | Injury, poisoning and procedural complications | — | — | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Skin abrasion | Injury, poisoning and procedural complications | — | — | — | — |
| Tooth fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Wrist fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Blood glucose increased | Investigations | — | — | — | — |
| Hepatic enzyme increased | Investigations | — | — | — | — |
| Neutrophil count increased | Investigations | — | — | — | — |
| Neutrophil percentage increased | Investigations | — | — | — | — |
| Weight increased | Investigations | — | — | — | — |
| White blood cell count increased | Investigations | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — | — | — | — |
| Ingrowing nail | Skin and subcutaneous tissue disorders | — | — | — | — |
| Tooth extraction | Surgical and medical procedures | — | — | — | — |
Most-reported serious reactions: Mastitis.
Data from ClinicalTrials.gov NCT03911102 adverse events section.
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Trials by the same sponsor.
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/NCT03911102.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing