NCT03326856

Brief Summary

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 10, 2021

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

October 27, 2017

Results QC Date

June 29, 2021

Last Update Submit

April 19, 2022

Conditions

Lateral Canthal LinesCrow's Feet

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2

    Composite of Investigators Global Assessment \& Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.

    Week 4

Secondary Outcomes (2)

  • Total Number of Observations With a Response Defined as IGA-C Score ≤ 2

    Week 2, 4, 8,12,18

  • Total Number of Observations With a Response Defined as SSA-C Score ≤ 2

    Week 2, 4, 8,12,18

Study Arms (5)

Vehicle

PLACEBO COMPARATOR

Vehicle

Biological: Vehicle

Dose 1

EXPERIMENTAL

botulinum toxin, Type A, Dose 1

Biological: botulinum toxin, Type A

Dose 2

EXPERIMENTAL

botulinum toxin, Type A, Dose 2

Biological: botulinum toxin, Type A

Dose 3

EXPERIMENTAL

botulinum toxin, Type A, Dose 3

Biological: botulinum toxin, Type A

Dose 4

EXPERIMENTAL

botulinum toxin, Type A, Dose 4

Biological: botulinum toxin, Type A

Interventions

botulinum toxin, Type ABIOLOGICAL

topical liniment

Also known as: ET-01
Dose 1Dose 2Dose 3Dose 4
VehicleBIOLOGICAL

Vehicle Formulation

Vehicle

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • minimal to moderate Crow's Feet wrinkles at rest
  • moderate to severe Crow's Feet wrinkles on contraction
  • willingness to refrain from any product affecting skin remodeling
  • female subjects must be not pregnant and non-lactating-

You may not qualify if:

  • history of adverse reactions to any prior botulinum toxin treatments
  • history of vaccination or non-response to any prior botulinum toxin treatments
  • botulinum toxin treatment in the prior 6 months
  • present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
  • history of peri-ocular surgery, brow lift or related procedures
  • procedures affecting the lateral canthal region in the prior 12 months
  • application of topical prescription medication to the treatment area
  • female subjects who are pregnant or are nursing a child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cary Skin Care

Cary, North Carolina, 27519, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Chief Executive Officer
Organization
Eirion Therapeutics
info@eirionthera.com
(781) 935-1216

Study Officials

  • Klaus Theobald, MD, PhD

    Eirion Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: sequential, dose escalating study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2017

First Posted

October 31, 2017

Study Start

October 25, 2017

Primary Completion

June 11, 2018

Study Completion

November 14, 2018

Last Updated

April 21, 2022

Results First Posted

September 10, 2021

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)