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NCT01485601

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

Completed Phase 2 Results posted Last updated 22 February 2024
What this trial tests

Phase 2 trial testing MT10109 in Glabellar Frown Lines in 121 participants. Completed in 17 August 2012.

Timeline
7 December 2011
Primary endpoint
30 March 2012
17 August 2012

Quick facts

Lead sponsorMedy-Tox
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment121
Start date7 December 2011
Primary completion30 March 2012
Estimated completion17 August 2012
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Medy-Tox — full company profile →

Who can join

Adults 18 to 75, any sex, with Glabellar Frown Lines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. Primary · at Day 30

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).

GroupValue95% CI
MT10109 A Unit18
MT0109 B Unit18
MT10109 C Unit22
Botox (Registered Trade Mark)19
MT10109 A Unit12
MT0109 B Unit8
MT10109 C Unit3
Botox (Registered Trade Mark)7

Adverse events — posted to ClinicalTrials.gov

Time frame: Until the End-of-Study Visit (Day 120). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MT10109 A Unit
Serious: 0/31 (0%)
Deaths:
MT10109 B Unit
Serious: 0/31 (0%)
Deaths:
MT10109 C Unit
Serious: 1/27 (4%)
Deaths:
Botox (Registered Trade Mark)
Serious: 1/32 (3%)
Deaths:

Serious adverse events (2 terms)

ReactionSystemMT10109 A UnitMT10109 B UnitMT10109 C UnitBotox (Registered Trade Ma…
CholelithiasisHepatobiliary disorders
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Other adverse events (36 terms — click to expand)

ReactionSystemMT10109 A UnitMT10109 B UnitMT10109 C UnitBotox (Registered Trade Ma…
HEADACHENervous system disorders
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations
NAUSEAGastrointestinal disorders
NODULEGeneral disorders
ACUTE TONSILLITISInfections and infestations
BRONCHITISInfections and infestations
EYELID INFECTIONInfections and infestations
GASTROENTERITISInfections and infestations
HERPES ZOSTERInfections and infestations
INFLUENZAInfections and infestations
LOWER RESPIRATORY TRACT INFECTIONInfections and infestations
OTITIS MEDIAInfections and infestations
RESPIRATORY TRACT INFECTIONInfections and infestations
URINARY TRACT INFECTIONInfections and infestations
VULVOVAGINAL CANDIDIASISInfections and infestations
CLAVICLE FRACTUREInjury, poisoning and procedural complications
LOWER LIMB FRACTUREInjury, poisoning and procedural complications
THERMAL BURNInjury, poisoning and procedural complications
VITAMIN D DEFICIENCYMetabolism and nutrition disorders
BACK PAINMusculoskeletal and connective tissue disorders
MUSCLE SPASMSMusculoskeletal and connective tissue disorders
TENOSYNOVITIS STENOSANSMusculoskeletal and connective tissue disorders
HEAD DISCOMFORTNervous system disorders
MIGRAINENervous system disorders
SYNCOPENervous system disorders
TENSION HEADACHENervous system disorders
DEPRESSIONPsychiatric disorders
RENAL COLICRenal and urinary disorders
BREAST MASSReproductive system and breast disorders
DYSMENORRHOEAReproductive system and breast disorders
ALOPECIASkin and subcutaneous tissue disorders
DERMATITIS ACNEIFORMSkin and subcutaneous tissue disorders
RASHSkin and subcutaneous tissue disorders
SEBACEOUS HYPERPLASIASkin and subcutaneous tissue disorders
TELANGIECTASIASkin and subcutaneous tissue disorders
CHOLELITHIASISHepatobiliary disorders

Most-reported serious reactions: Cholelithiasis, Breast Cancer.

Data from ClinicalTrials.gov NCT01485601 adverse events section.

Sponsor's own description

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®

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Botulinum toxin type A for facial wrinkles.
    Camargo CP, Xia J, Costa CS, Gemperli R, et al · · 2021 · cited 21× · PMID 34224576 · DOI 10.1002/14651858.cd011301.pub2

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01485601.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing