CompletedNCT01485601Updated Feb 22, 2024Results posted

Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

A Phase 2 interventional study of MT10109 in Glabellar Frown Lines, sponsored by Medy-Tox. Completed at 1 site in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-22.

Sponsored by Medy-Tox · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 121
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

Conditions studied

Glabellar Frown 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.

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

Who can participate

Ages eligible: 18 Years to 75 Years
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

Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
Women of must have a negative serum pregnancy test at screening

Exclusion criteria

Exclusion Criteria:

Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
Patients with an anaphylactic response history to botulinum toxin type A.
Patients who have been administered botulinum toxin type A within the previous 6 months.
Pregnant or lactating women.
Participation in any research study involving drug administration within 90 days preceding enrollment.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 121 participants (actual)

Study arms

Experimental
MT10109
Clostridium botulinum toxin type A
Biological: MT10109
Active comparator
Botox (registered trade mark)
Clostridium botulinum toxin type A
Biological: MT10109

Interventions

BiologicalMT10109
Single dose intramuscular injection MT10109 vs Botox®

What researchers measure

Primary outcomes

Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).
Time frame: at Day 30

Results

Posted Feb 22, 2024

Participant flow

Participant flow — Overall Study
Milestone	MT10109 A Unit	MT10109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)
Started	31	31	27	32
Completed	28	23	25	26
Not completed	3	8	2	6

Outcome measures

PrimaryInvestigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.

Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).

Time frame:: at Day 30
Reported as:: Count of participants · Participants

Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Participants	MT10109 A Unit	MT0109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)
Responders at Day 30 at Max Frown	18	18	22	19
Non-responders at Day 30 at Max Frown	12	8	3	7

Adverse events

Collected over Until the End-of-Study Visit (Day 120). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MT10109 A Unit	—	0/31 (0%)	7/31 (22.6%)
MT10109 B Unit	—	0/31 (0%)	7/31 (22.6%)
MT10109 C Unit	—	1/27 (3.7%)	10/27 (37%)
Botox (Registered Trade Mark)	—	1/32 (3.1%)	10/32 (31.3%)

Most frequent serious events

Most frequent serious events
Event	MT10109 A Unit	MT10109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/31	0/31	1/27	0/32
CholelithiasisHepatobiliary disorders	0/31	0/31	0/27	1/32

Most frequent other events

Showing 10 of 36

Most frequent other events
Event	MT10109 A Unit	MT10109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)
HEADACHENervous system disorders	1/31	1/31	0/27	4/32
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations	2/31	1/31	0/27	3/32
ACUTE TONSILLITISInfections and infestations	0/31	0/31	1/27	0/32
EYELID INFECTIONInfections and infestations	0/31	0/31	1/27	0/32
GASTROENTERITISInfections and infestations	0/31	0/31	1/27	0/32
INFLUENZAInfections and infestations	1/31	0/31	1/27	0/32
LOWER RESPIRATORY TRACT INFECTIONInfections and infestations	0/31	0/31	1/27	0/32
OTITIS MEDIAInfections and infestations	0/31	0/31	1/27	0/32
VULVOVAGINAL CANDIDIASISInfections and infestations	0/31	0/31	1/27	0/32
THERMAL BURNInjury, poisoning and procedural complications	0/31	0/31	1/27	0/32

Baseline characteristics

Safety Set

Age, Customized
Age, Customized(years)	MT10109 A Unit	MT10109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)	Total
Age	44.9 ± 8.32	44.0 ± 9.77	45.3 ± 9.51	45.1 ± 9.53	44.8 ± 9.19

Sex: Female, Male
Sex: Female, Male(Participants)	MT10109 A Unit	MT10109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)	Total
Female	27	29	24	27	107
Male	4	2	3	5	14

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	MT10109 A Unit	MT10109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)	Total
Hispanic or Latino	0	0	0	1	1
Not Hispanic or Latino	31	31	27	31	120
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	MT10109 A Unit	MT10109 B Unit	MT10109 C Unit	Botox (Registered Trade Mark)	Total
Australia	31	31	27	32	121

Study locations

1 site

Melbourne, Australia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01485601
Lead sponsor: Medy-Tox
Responsible party: Sponsor
First posted: Dec 5, 2011
Start date: Dec 7, 2011
Primary completion: Mar 30, 2012
Completion: Aug 17, 2012
Results posted: Feb 22, 2024
Last update: Feb 22, 2024

Study contacts

Peter Foley, Doctor

principal investigator · Austrailia

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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