Last reviewed · How we verify
ET-01 in Subjects With Lateral Canthal Lines, LCL-209
Phase 2 trial testing botulinum toxin, Type A in Lateral Canthal Lines, LCL in 38 participants. Completed in 4 October 2019.
| Lead sponsor | Eirion Therapeutics Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 27 February 2019 |
| Primary completion | 6 May 2019 |
| Estimated completion | 4 October 2019 |
| Sites | 3 locations across United States |
Eirion Therapeutics Inc. — full company profile →
Adults 25 to 65, female only, with Lateral Canthal Lines, LCL or Crow's Feet. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
| Group | Value | 95% CI |
|---|---|---|
| Vehicle | 3 | |
| ET-01 1610U | 1 |
Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
| Group | Value | 95% CI |
|---|---|---|
| Vehicle | 8 | |
| ET-01 1610U | 12 |
Total number of observations with a change in the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
| Group | Value | 95% CI |
|---|---|---|
| Vehicle | 15 | |
| ET-01 1610U | 20 |
Time frame: 26 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Vehicle | ET-01 1610U |
|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | — | — |
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Thermal Burn | Skin and subcutaneous tissue disorders | — | — |
| Folliculitis | Skin and subcutaneous tissue disorders | — | — |
| Endodontic Procedure | Surgical and medical procedures | — | — |
| Oral Herpes | General disorders | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hordeolum | Eye disorders | — | — |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | — | — |
Data from ClinicalTrials.gov NCT03912805 adverse events section.
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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/NCT03912805.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing