A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines
Phase: PHASE3
Conditions: Lateral Canthal Lines
Sponsor: Medy-Tox

CONFIDENTIAL
Protocol MT10109L-002 AMD 4
MT10109L
1
Title Page
Protocol Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group 
Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the 
Treatment of Lateral Canthal Lines
Protocol Number: MT10109L-002
Amendment Number: Amendment 4
Product: MT10109L (NivobotulinumtoxinA)
Brief Protocol Title: MT10109L in the Treatment of Lateral Canthal Lines
Development Phase: 3
Regulatory Agency Identifying Numbers: IND Number 121473;
EudraCT Number 2014-005279-10
Refer to the final page of this protocol for electronic signature and date of approval.
Approval Date: 30-Sep-2020 22:56:17 (GMT)

CONFIDENTIAL
Protocol MT10109L-002 AMD 4
MT10109L
8
Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

CONFIDENTIAL
Protocol MT10109L-002 AMD 4
MT10109L
22
5.
Study Population
Participants in the current study have moderate to severe LCL at maximum smile, as specified in 
Section 5.1.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted.
5.1.
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

30
6.2.
Preparation/Handling/Storage/Accountability
1. The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are 
reported and resolved before use of the study intervention.
2. Only participants enrolled in the study may receive study intervention, and only authorized 
site personnel may administer study intervention. All study intervention must be stored in a 
secure, environmentally controlled, and monitored (manual or automated) area in accordance 
Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

CONFIDENTIAL
Protocol MT10109L-002 AMD 4
MT10109L
58
10.1.3.
Informed Consent Process

The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions regarding the 
study.

Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, HIPAA requirements, where applicable, and the IRB/IEC 
or study center.

The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained. 
The authorized person obtaining the informed consent must also sign the ICF.

Participants must be reconsented to the most current version of the ICF(s) during their 
participation in the study.

A copy of the ICF(s) must be provided to the participant or the participant’s legally 
authorized representative.
Participants who are rescreened are required to sign a new ICF.
10.1.4.
Data Protection

Participants will be assigned a unique identifier. Any participant records or datasets that are 
transferred to the sponsor will contain the identifier only; participant names or any 
information which would make the participant identifiable will not be transferred.

The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.

The participant must be informed that his/her medical records may be examined by clinical 
quality assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities.
10.1.5.
Posting Clinical Study Data

Study data and information may be published in nonpromotional, peer-reviewed publications 
either by or on behalf of the sponsor. 

Clinical study reports, safety updates, and annual reports will be provided to regulatory 
authorities as required.

Company-sponsored study information and tabular study results will be posted on the US 
National Institutes of Health's website www.ClinicalTrials.gov and other publicly accessible 
sites
Approval Date: 30-Sep-2020 22:56:17 (GMT)

CONFIDENTIAL
Protocol MT10109L-002 AMD 4
MT10109L
59
10.1.6.
Data Quality Assurance

All participant data relating to the study will be recorded on printed or eCRFs unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the eCRF.

The investigator must maintain accurate documentation (source data) that supports the 
information entered in the eCRF.

The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.

The sponsor or designee is responsible for the data management of this study including 
quality checking of the data.

Study monitors will perform ongoing source data verification to confirm that data entered 
into the eCRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements.

Records and documents, including signed ICFs, pertaining to the conduct of this study must 
be retained by the investigator as stated in the clinical trial agreement. No records may be 
destroyed during the retention period without the written approval of the sponsor. No records 
may be transferred to another location or party without written notification to the sponsor.
10.1.7.
Source Documents

Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site.

Data reported on the CRF or entered in the eCRF that are transcribed from source documents 
must be consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study.

Definition of what constitutes source data can be found in Section 4.0 of ICH E6, Good 
Clinical Practice: Consolidated Guidance and must follow ALCOA, ie, records must be 
attributable, legible, contemporaneous, original, and accurate.
10.1.8.
Study and Site Closure
The sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed.
Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

CONFIDENTIAL
Protocol MT10109L-002 AMD 4
MT10109L
94
10.10.
Appendix 10: Protocol Amendment History
The protocol amendment summary of changes table for the current amendment is located 
directly before the table of contents.
Approval Date: 30-Sep-2020 22:56:17 (GMT)

Approval Date: 30-Sep-2020 22:56:17 (GMT)

Electronic Signatures
User
Date
Justification
Approval Date: 30-Sep-2020 22:56:17 (GMT)