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ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Phase 2 trial testing botulinum toxin, Type A in Lateral Canthal Lines in 75 participants. Completed in 19 September 2019.
| Lead sponsor | Eirion Therapeutics Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 16 October 2018 |
| Primary completion | 18 April 2019 |
| Estimated completion | 19 September 2019 |
| Sites | 5 locations across United States |
Eirion Therapeutics Inc. — full company profile →
Adults 25 to 65, female only, with Lateral Canthal Lines 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 | 2 | |
| ET-01 345U | 0 | |
| ET-01 1100U | 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 | 1 | |
| ET-01 345U | 5 | |
| ET-01 1100U | 5 |
Total number of observations with a change by at least two ordinals in the Subjects 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 an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12.
| Group | Value | 95% CI |
|---|---|---|
| Vehicle | 4 | |
| ET-01 345U | 6 | |
| ET-01 1100U | 8 |
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 345U | ET-01 1100U |
|---|---|---|---|---|
| Hordeolum | Eye disorders | — | — | — |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Headache | General disorders | — | — | — |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Application site pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Blepharitis | Eye disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Cough | Gastrointestinal disorders | — | — | — |
| Cystitis | Renal and urinary disorders | — | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — | — |
| Dry throat | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Ear infection | Ear and labyrinth disorders | — | — | — |
| Endodontic procedure | Surgical and medical procedures | — | — | — |
| Endometrial ablation | Reproductive system and breast disorders | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Mammoplasty | Surgical and medical procedures | — | — | — |
| Nail dystrophy | Skin and subcutaneous tissue disorders | — | — | — |
| Nausea | Nervous system disorders | — | — | — |
| Rhinitis allergic | Skin and subcutaneous tissue disorders | — | — | — |
| Skin discolouration | Skin and subcutaneous tissue disorders | — | — | — |
| Thyroiditis subacute | Endocrine disorders | — | — | — |
Data from ClinicalTrials.gov NCT03839693 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.
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