Clinical trial NCT01237977: Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines
Official title: Double-blind, Randomized, Active Drug Comparative, Parallel Designed, Multi-center,Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of "Meditoxin® Versus Botox® in the Treatment of Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Aging
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 314
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity
timeFrame: 0 and 4 weeks after the injection
Secondary outcomes:
measure: Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
timeFrame: 0, 8, 12 and 16 weeks after the injection
measure: Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity
timeFrame: 0, 4, 8, 12 and 16 weeks after the injection
measure: Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment
timeFrame: 0, 4, 8,12 and 16 weeks after the injection
measure: Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity
timeFrame: 0, 4, 8, 12 and 16 weeks after the injection
measure: Glabellar line improvement rate confirmed with subject's assessment
timeFrame: 4, 8, 12 and 16 weeks after the injection
measure: Subject satisfaction rate
timeFrame: 4, 8, 12 and 16 weeks after the injection
Other outcomes:
Locations:
city: Seongnam si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyoung-gi Do
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Sevrance Medical Center
city: Seoul
country: Korea, Republic of
facility: St. Paul Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Yong-San Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hun Huh, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Paul Hospital
name: Hoon Kang, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kang-Buk Samsung Medical Center
name: Won-Seok Kim, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Asan Medical Center
name: Jong-Hyun Won, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sevrance Medical Center
name: Joo-Hee Lee, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Yong-San Hospital
name: Beom-Joon Kim, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.