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

Skin Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237977
• Other study ID #: CSP-MDTX-GL-0901
• Status: Completed
• Phase: Phase 3
• Start date: November 23, 2009
• Est. completion date: September 30, 2010

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: September 30, 2010
• Est. primary completion date: August 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Aging

Intervention

Drug:
• Botulinum Toxin Type A(Meditoxin®)
single administration, Day 0, 20U
• Botulinum Toxin Type A(Botox®)
single administration, Day 0, 20U

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam si	Gyoung-gi Do
Korea, Republic of	Chung-Ang University Yong-San Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Seoul Asan Medical Center	Seoul
Korea, Republic of	Sevrance Medical Center	Seoul
Korea, Republic of	St. Paul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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 — View 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. — View 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. — View Citation

Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 and 4 weeks after the injection
Secondary	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	0, 8, 12 and 16 weeks after the injection
Secondary	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	0, 4, 8, 12 and 16 weeks after the injection
Secondary	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	0, 4, 8,12 and 16 weeks after the injection
Secondary	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	0, 4, 8, 12 and 16 weeks after the injection
Secondary	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	4, 8, 12 and 16 weeks after the injection
Secondary	Subject satisfaction rate	Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection	4, 8, 12 and 16 weeks after the injection