CompletedNCT04157686Updated Aug 9, 2024Results posted

MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

A Phase 3 interventional study of MT10109L Dose 1 and MT10109L Dose 2 in Glabellar Lines and Lateral Canthal Lines, sponsored by Medy-Tox. Completed at 38 sites in 6 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 957
Allocation: Non-randomized
Ages: 19 Years and older
Sex: All

Study summary

To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Read the detailed description

Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study.

Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies.

The safety and efficacy data from the lead-in and this open-label extension will be summarized.

Conditions studied

Glabellar Lines
Lateral Canthal Lines

In context

Lead sponsor

Medy-Tox is the lead sponsor of 49 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Browse Medy-Tox studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Completion of lead-in Phase 3 study;
Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion criteria

Exclusion Criteria:

Known immunization or to any botulinum toxin serotype;
Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function;
Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures;
Females who are pregnant, nursing, or planning a pregnancy during the study;
Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity: An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 957 participants (actual)

Study arms

Experimental
Placebo/MT10109L Dose 1
The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study
Drug: MT10109L Dose 1
Experimental
Placebo/MT10109L Dose 2
The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.
Drug: MT10109L Dose 2
Experimental
Placebo/MT10109L Dose 1 + Dose 2
The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
Drug: MT10109L Dose 1 + Dose 2
Experimental
MT10109L Dose 1/Dose 1
The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study.
Drug: MT10109L Dose 1
Experimental
MT10109L Dose 2/Dose 2
The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.
Drug: MT10109L Dose 2
Experimental
MT10109L Dose 1/Dose 1+2
The participant pool in this arm are from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
Drug: MT10109L Dose 1 + Dose 2
Experimental
MT10109L Dose 2/Dose 1+2
The participant pool in this arm are from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
Drug: MT10109L Dose 1 + Dose 2
Experimental
MT10109L Dose 1+2/Dose 1+2
The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
Drug: MT10109L Dose 1 + Dose 2

Interventions

DrugMT10109L Dose 1
MT10109L Dose 1 will be injected into the GL area
DrugMT10109L Dose 2
MT10109L Dose 2 will be injected into the LCL area
DrugMT10109L Dose 1 + Dose 2
MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area

What researchers measure

Primary outcomes

Number of Participants Who Experienced Any Adverse Event (AE)
The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.
Time frame: Baseline to Day 720 or Study Exit
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)
This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.
Time frame: Baseline to Day 720 or Study exit
Mean Change From Baseline in Pulse Rate (Beats Per Minute)
The outcome reported here is the mean change in pulse rate from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)
The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)
The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
The outcome reported here is the mean change in respiratory rate from baseline to study exit.
Time frame: Baseline to Day 720 or Study Exit
Number of Participants With Binding and Neutralizing Antibodies
Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.
Time frame: Baseline to Day 720 or Study Exit

Results

Posted Aug 9, 2024

Participant flow

Approximately 800 participants were planned to be enrolled. A total of 957 participants were enrolled and treated, and 759 participants completed the study. There were 957 participants in the intent-to-treat (ITT) population, which were used for the efficacy of US FDA and safety analyses.

Participant flow — Overall Study
Milestone	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Started	55	56	118	116	108	128	123	253
Completed	43	41	89	87	83	106	92	218
Not completed	12	15	29	29	25	22	31	35
Withdrew: Adverse event	1	0	1	0	1	0	0	0
Withdrew: Pregnancy	0	1	3	0	0	0	3	0
Withdrew: Lost to follow-up	1	2	8	6	6	3	7	9
Withdrew: Lack of efficacy	0	0	0	0	0	2	0	1
Withdrew: Withdrawal by subject	10	10	12	20	12	11	18	24
Withdrew: Physician decision	0	0	1	0	1	0	3	0
Withdrew: Death	0	0	0	2	0	0	0	0
Withdrew: Protocol violation	0	0	0	0	1	0	0	0
Withdrew: Covid-19, family reasons etc.	0	2	4	1	4	6	0	1

Outcome measures

PrimaryNumber of Participants Who Experienced Any Adverse Event (AE)

The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.

Time frame:: Baseline to Day 720 or Study Exit
Reported as:: Count of participants · Participants

Number of Participants Who Experienced Any Adverse Event (AE)
Participants	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Number of Participants Who Experienced Any Adverse Event (AE)	39	39	80	89	74	80	89	183

PrimaryNumber of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)

This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.

Time frame:: Baseline to Day 720 or Study exit
Reported as:: Count of participants · Participants

Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)
Participants	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)	18	4	31	34	11	22	42	73

PrimaryMean Change From Baseline in Pulse Rate (Beats Per Minute)

The outcome reported here is the mean change in pulse rate from baseline to study exit.

Time frame:: Baseline to Day 720 or Study Exit
Reported as:: Mean · beats/min

Mean Change From Baseline in Pulse Rate (Beats Per Minute)
beats/min	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Mean Change From Baseline in Pulse Rate (Beats Per Minute)	3.2 ± 15.01	-2.2 ± 13.35	-1.2 ± 10.95	2.0 ± 12.77	0.6 ± 11.58	0.7 ± 10.97	3.0 ± 10.34	1.0 ± 8.93

PrimaryMean Change From Baseline in Systolic Blood Pressure (mm Hg)

The outcome reported here is the mean change in Systolic BP from baseline to study exit.

Time frame:: Baseline to Day 720 or Study Exit
Reported as:: Mean · mmHg

Mean Change From Baseline in Systolic Blood Pressure (mm Hg)
mmHg	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)	1.4 ± 12.59	-1.9 ± 10.44	1.9 ± 14.44	0.6 ± 16.72	1.1 ± 13.84	1.8 ± 15.24	1.4 ± 14.17	-0.4 ± 13.83

PrimaryMean Change From Baseline in Diastolic Blood Pressure (mm Hg)

The outcome reported here is the mean change in Diastolic BP from baseline to study exit.

Time frame:: Baseline to Day 720 or Study Exit
Reported as:: Mean · mmHg

Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)
mmHg	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)	1.1 ± 11.3	-0.6 ± 11.75	1.3 ± 9.61	1.5 ± 11.68	0.7 ± 7.57	0.0 ± 10.62	2.3 ± 9.53	-0.3 ± 9.46

PrimaryMean Change From Baseline in Respiratory Rate (Breaths Per Minute)

The outcome reported here is the mean change in respiratory rate from baseline to study exit.

Time frame:: Baseline to Day 720 or Study Exit
Reported as:: Mean · breaths/min

Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
breaths/min	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)	0.3 ± 2.09	0.6 ± 2.15	-0.5 ± 1.92	0.2 ± 2.78	0.5 ± 1.94	-0.4 ± 2.29	0.4 ± 2.21	-0.1 ± 2.3

PrimaryNumber of Participants With Binding and Neutralizing Antibodies

Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.

Time frame:: Baseline to Day 720 or Study Exit
Reported as:: Count of participants · Participants

Number of Participants With Binding and Neutralizing Antibodies
Participants	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Number of Participants With Binding and Neutralizing Antibodies	0	0	0	0	2	0	0	1

Adverse events

Collected over The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo/MT10109L Dose 1	0/55 (0%)	3/55 (5.5%)	26/55 (47.3%)
Placebo/MT10109L Dose 2	0/56 (0%)	1/56 (1.8%)	23/56 (41.1%)
Placebo/MT10109L Dose 1 + Dose 2	0/118 (0%)	10/118 (8.5%)	58/118 (49.2%)
MT10109L Dose 1/Dose 1	2/116 (1.7%)	8/116 (6.9%)	54/116 (46.6%)
MT10109L Dose 2/Dose 2	0/108 (0%)	9/108 (8.3%)	45/108 (41.7%)
MT10109L Dose 1/Dose 1+2	0/128 (0%)	7/128 (5.5%)	50/128 (39.1%)
MT10109L Dose 2/Dose 1+2	0/123 (0%)	13/123 (10.6%)	60/123 (48.8%)
MT10109L Dose 1+2/Dose 1+2	0/253 (0%)	13/253 (5.1%)	128/253 (50.6%)

Most frequent serious events

Showing 10 of 55

Most frequent serious events
Event	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/55	0/56	2/118	0/116	0/108	1/128	3/123	3/253
Radius fractureInjury, poisoning and procedural complications	1/55	0/56	0/118	0/116	0/108	0/128	1/123	0/253
Intentional overdoseInjury, poisoning and procedural complications	1/55	0/56	0/118	0/116	0/108	0/128	0/123	0/253
Road traffic accidentInjury, poisoning and procedural complications	1/55	0/56	0/118	0/116	0/108	0/128	0/123	0/253
Malignant melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/55	0/56	0/118	0/116	1/108	0/128	1/123	0/253
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/55	1/56	0/118	0/116	0/108	1/128	0/123	0/253
COVID-19 pneumoniaInfections and infestations	0/55	0/56	0/118	2/116	1/108	2/128	0/123	1/253
SyncopeNervous system disorders	0/55	0/56	0/118	0/116	0/108	0/128	2/123	0/253
COVID-19Infections and infestations	0/55	0/56	0/118	1/116	1/108	1/128	1/123	0/253
Subcutaneous abscessInfections and infestations	0/55	0/56	0/118	0/116	1/108	0/128	0/123	0/253

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
COVID-19Infections and infestations	7/55	12/56	22/118	18/116	31/108	20/128	22/123	47/253
HeadacheNervous system disorders	12/55	1/56	11/118	12/116	5/108	13/128	13/123	27/253
Injection site painGeneral disorders	8/55	0/56	10/118	17/116	0/108	8/128	17/123	23/253
NasopharyngitisInfections and infestations	6/55	4/56	15/118	9/116	8/108	9/128	17/123	31/253
Injection site bruisingGeneral disorders	0/55	0/56	8/118	3/116	0/108	4/128	12/123	20/253
Upper respiratory tract infectionInfections and infestations	0/55	0/56	11/118	6/116	5/108	7/128	5/123	15/253
SinusitisInfections and infestations	2/55	5/56	4/118	3/116	4/108	3/128	3/123	7/253
HypertensionVascular disorders	4/55	2/56	3/118	5/116	3/108	3/128	6/123	9/253
Injection site haemorrhageGeneral disorders	1/55	3/56	8/118	0/116	6/108	2/128	7/123	11/253
Ligament SprainInjury, poisoning and procedural complications	3/55	0/56	1/118	3/116	1/108	0/128	3/123	3/253

Baseline characteristics

Participants pool in this open-label extension study flowed from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). 957 participants were included in the Intent-To-Treat (ITT) population.

Age, Categorical
Age, Categorical(Participants)	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2	Total
<=18 years	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	54	54	110	107	103	120	113	241	902
>=65 years	1	2	8	9	5	8	10	12	55

Age, Continuous
Age, Continuous(years)	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2	Total
Mean	47.1 ± 10.18	46.7 ± 11.75	48.2 ± 11.68	46.9 ± 12.17	47.1 ± 10.34	47.8 ± 11.24	48.5 ± 10.53	47.9 ± 10.80	47.7 ± 11.06

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2	Total
Female	53	42	99	106	87	109	103	227	826
Male	2	14	19	10	21	19	20	26	131

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2	Total
Hispanic or Latino	1	5	12	3	17	19	5	23	85
Not Hispanic or Latino	54	51	106	113	91	109	118	230	872
Unknown or Not Reported	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2	Total
American Indian or Alaska Native	0	0	0	0	1	1	0	3	5
Asian	1	1	1	1	4	3	3	4	18
Native Hawaiian or Other Pacific Islander	0	0	1	0	0	0	0	0	1
Black or African American	1	2	3	3	2	1	1	4	17
White	53	53	113	112	101	123	119	241	915
More than one race	0	0	0	0	0	0	0	1	1
Unknown or Not Reported	0	0	0	0	0	0	0	0	0

Study locations

38 sites

Clear Dermatology & Aesthetics Center
Scottsdale, Arizona 85255-4134, United States
The Eye Research Foundation
Newport Beach, California 92663-3637, United States
Art of Skin MD
Solana Beach, California 92075-2228, United States
Susan H. Weinkle
Bradenton, Florida 34209-5642, United States
Skin Research Institute
Coral Gables, Florida 33146-1837, United States
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana 70006, United States
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana 70130-4353, United States
MD Laser Skin & Vein
Hunt Valley, Maryland 21030, United States
Laser & Skin Surgery Center of New York
New York, New York 10016-4974, United States
Skin Search of Rochester Inc.
Rochester, New York 14623, United States
M3 Wake Research Inc.
Raleigh, North Carolina 27612-8106, United States
Wilmington Dermatology Center
Wilmington, North Carolina 28403, United States
Aventiv Research Dublin
Dublin, Ohio 43016, United States
Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas 78746-4720, United States
DermResearch Inc.
Austin, Texas 78759, United States
Bellaire Dermatology
Bellaire, Texas 77401, United States
SkinDC
Arlington, Virginia 22209, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia 23507, United States
UZ Brussel
Jette, Bruxelles-Capitale 1090, Belgium
Medical Skincare
Sint-Truiden, Limburg 3800, Belgium
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia V5Z 4E1, Canada
Project Skin MD LTD
Vancouver, British Columbia V6H 1K9, Canada
Pacific Derm
Vancouver, British Columbia V6H 4E1, Canada
Sweat Clinics of Canada
Toronto, Ontarion M5R 3N8, Canada
Dermetics Cosmetic Dermatology
Burlington, Ontario L7N 3N2, Canada
The Center For Dermatology
Richmond Hill, Ontario L4B 1A5, Canada
Rosenpark Research
Darmstadt, 64283, Germany
Privatpraxis Dr. Hilton & Partner
Duesseldorf, 40212, Germany
Hautok and Hautok-cosmetics
Muenchen, 80333, Germany
Studienzentrum Theatiner46
Muenchen, 80333, Germany
MediCorium Zentrum fuer Dermatologie und Aesthetik
Oberursel, 61440, Germany
Kazan State Medical University
Kazan, 420012, Russian Federation
Medical Center Capital - Zdorovie LLC
Moscow, 109369, Russian Federation
Center dermatovenereology and cosmetology
Moscow, 119071, Russian Federation
State Budget Institution of Higher Education North
Saint-Petersburg, 194291, Russian Federation
Meyer Clinic
Chichester, PO18 8AN, United Kingdom
NHS Lanarkshire
Glasgow, G71 8BB, United Kingdom
MediZen Premier Aesthetic Clinic
Sutton Coldfield, B74 2UG, United Kingdom

References and documents

Study documents

Study protocol ↗ · Jun 1, 2022
Statistical analysis plan ↗ · Aug 14, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04157686
Lead sponsor: Medy-Tox
Responsible party: Sponsor
First posted: Nov 8, 2019
Start date: Oct 23, 2019
Primary completion: Feb 16, 2023
Completion: Feb 16, 2023
Results posted: Aug 9, 2024
Last update: Aug 9, 2024

Study contacts

SangMi Park

study director · Medytox Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Nivobotulinumtoxina

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