Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines
NCT ID: NCT01237977
Last Updated: 2019-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
314 participants
INTERVENTIONAL
2009-11-23
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Botulinum toxin type A(Meditoxin®)
Botulinum Toxin Type A(Meditoxin®)
single administration, Day 0, 20U
Botulinum toxin type A(Botox®)
Botulinum Toxin Type A(Botox®)
single administration, Day 0, 20U
Interventions
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Botulinum Toxin Type A(Meditoxin®)
single administration, Day 0, 20U
Botulinum Toxin Type A(Botox®)
single administration, Day 0, 20U
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
65 Years
ALL
No
Sponsors
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Medy-Tox
INDUSTRY
Responsible Party
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Principal Investigators
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Chang-Hun Huh, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Hoon Kang, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
St. Paul Hospital
Won-Seok Kim, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kang-Buk Samsung Medical Center
Jong-Hyun Won, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul Asan Medical Center
Joo-Hee Lee, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Sevrance Medical Center
Beom-Joon Kim, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Yong-San Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyoung-gi Do, South Korea
Kangbuk Samsung Medical Center
Seoul, , South Korea
Sevrance Medical Center
Seoul, , South Korea
St. Paul Hospital
Seoul, , South Korea
Seoul Asan Medical Center
Seoul, , South Korea
Chung-Ang University Yong-San Hospital
Seoul, , South Korea
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CSP-MDTX-GL-0901
Identifier Type: -
Identifier Source: org_study_id
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