To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines

Skin Aging Clinical Trial

Official title:

Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791920
• Other study ID #: HG-11-01
• Status: Completed
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men and women aged between 18 and 65

• Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown

• Patients who voluntarily sign the informed consent

• Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

• Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy

• Subjects with skin disorders, scar or infection around glabellar region

• Subjects who are taking Aspirin, NSAIDS or anti-coagulant

• Subjects with facial palsy or eyelid ptosis

• Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)

• Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder

• Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)

• Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)

• Subject who have administered following drugs within the previous 4 months:

Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants

• Subjects who have possibility to take the drugs listed above

• Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period

• Subjects who have glabellar lines that are unable to be improved with any physical method

• Subjects who have history of hypersensitivity to Botulinum toxin and other agents

• Subjects who are pregnant or breast-feeding

• Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive

• Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product

• Subjects who are having trouble with acute disease

• Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months

• Subjects who are unable to communicate or follow the instructions

• Subjects who are not eligible for this study based on investigator's judgement

Related Conditions & MeSH terms

• Skin Aging

Intervention

Drug:
• Botulinum toxin type A(Botulax®)
Single administration, Day 0, 20 units
• Botulinum toxin type A(Botox®)
Single administration, Day 0, 20units

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hopspital	Seoul	Dongjak-gu
Korea, Republic of	Eulji General Hospital	Seoul	Nowon-Gu
Korea, Republic of	Korea University Anam Hospital	Seoul	Seongbuk-Gu
Korea, Republic of	National Medical Center	Seoul	Jung-Gu
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-Gu
Korea, Republic of	The catholic university of Korea, Seoul ST. Mary's Hospital	Seoul	Seocho-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate of improvement in glabellar lines with Physician's rating of line severity	Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.	at 4 weeks post-injection
Secondary	Safety evaluation in experimental drug treatment group		4, 8, 12, 16 weeks post-injection
Secondary	Responder rate of improvement in glabellar lines with Physician's rating of line severity	Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection.	8, 12, 16 weeks post-injection
Secondary	Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity	Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post-injection
Secondary	Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment	Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post-injection
Secondary	Responder rate of improvement in glabellar lines at rest with investigator's photo assessment	Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post inejection
Secondary	Responder rate of improvement in glabellar lines with Subject's improvement assessment	Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection	4, 8, 12, 16 weeks post-injections
Secondary	Subject's satisfaction rate	Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection	4, 8, 12, 16 weeks post-injection