CompletedNCT01237977Updated Mar 28, 2019

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

A Phase 3 interventional study of Botulinum Toxin Type A(Meditoxin®) and Botulinum Toxin Type A(Botox®) in Skin Aging, sponsored by Medy-Tox. Completed at 6 sites in South Korea. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-28.

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

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Nov 2009, registered Nov 2010).

Phase: Phase 3
Study type: Interventional
Enrollment: 314
Allocation: Randomized
Ages: 20 Years to 65 Years
Sex: All

Study summary

The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.

Read the detailed description

The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.

Conditions studied

Skin Aging

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: 20 Years to 65 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

Men and women aged between 20 and 65
Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
Patients who can comply with the study procedures and visit schedule
Patients who voluntarily sign the informed consent

Exclusion criteria

Exclusion Criteria:

Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
Patients with severe internal diseases (cardiovascular, respiratory, endocrine diseases etc.)
Patients who have bleeding tendency or taking anti-coagulant
Patients who were injected with botulinum toxin within the past 3 months
Patients with allergy or hypersensitivity to the investigational drugs or their components
Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
Patients with skin disorders or infection at the injection site
Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
Patients with the history of treatment of glabellar part(including forehead) like face lifting and permanent implant or with scars which may affect the treatment results
Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period
Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening or the five times the half life of a drug which was given to patient during the previous clinical trials
Patients who are unable to communicate or follow the instructions
Patients who are not eligible for this study based on the judgment of an investigator

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 314 participants (actual)

Study arms

Experimental
Botulinum toxin type A(Meditoxin®)
Drug: Botulinum Toxin Type A(Meditoxin®)
Active comparator
Botulinum toxin type A(Botox®)
Drug: Botulinum Toxin Type A(Botox®)

Interventions

DrugBotulinum Toxin Type A(Meditoxin®)
single administration, Day 0, 20U
Also known as: Neuronox®, Siax®
DrugBotulinum Toxin Type A(Botox®)
single administration, Day 0, 20U

What researchers measure

Primary outcomes

Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection
Time frame: 0 and 4 weeks after the injection

Secondary outcomes

Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection
Time frame: 0, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection
Time frame: 0, 4, 8,12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate confirmed with subject's assessment
Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection
Time frame: 4, 8, 12 and 16 weeks after the injection
Subject satisfaction rate
Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection
Time frame: 4, 8, 12 and 16 weeks after the injection

Study locations

6 sites

Seoul National University Bundang Hospital
Seongnam-si, Gyoung-gi Do 463-707, South Korea
Kangbuk Samsung Medical Center
Seoul, 110-746, South Korea
Sevrance Medical Center
Seoul, 120-749, South Korea
St. Paul Hospital
Seoul, 130-709, South Korea
Seoul Asan Medical Center
Seoul, 138-736, South Korea
Chung-Ang University Yong-San Hospital
Seoul, 140-013, South Korea

References and documents

Publications

Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; Botox Glabellar Lines II Study Group. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62. PubMed 12973229 ↗
Kriegl L, Horst D, Kirchner T, Jung A. LEF-1 expression in basal cell carcinomas. Br J Dermatol. 2009 Jun;160(6):1353-6. doi: 10.1111/j.1365-2133.2009.09144.x. Epub 2009 Mar 30. No abstract available. PubMed 19416246 ↗
Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e. PubMed 9463853 ↗
Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics. 1977 Jun;33(2):363-74. No abstract available. PubMed 884196 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2009 to primary completion in Aug 2010, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 4, 2010
First posted: Nov 10, 2010
StartActual: Nov 23, 2009
Primary completionActual: Aug 30, 2010
CompletionActual: Sep 30, 2010
Last update: Mar 28, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01237977
Lead sponsor: Medy-Tox
Responsible party: Sponsor
First posted: Nov 10, 2010
Start date: Nov 23, 2009
Primary completion: Aug 30, 2010
Completion: Sep 30, 2010
Last update: Mar 28, 2019

Study contacts

Chang-Hun Huh, MD, Ph.D.

principal investigator · Seoul National University Bundang Hospital

Hoon Kang, MD, Ph.D.

principal investigator · St. Paul Hospital

Won-Seok Kim, MD, Ph.D.

principal investigator · Kang-Buk Samsung Medical Center

Jong-Hyun Won, MD, Ph.D.

principal investigator · Seoul Asan Medical Center

Joo-Hee Lee, MD, Ph.D.

principal investigator · Sevrance Medical Center

Beom-Joon Kim, MD, Ph.D.

principal investigator · Chung-Ang University Yong-San Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Botulinum toxin type A

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