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

NCT01237977 | Completed Phase 3

• 1 other identifier: CSP-MDTX-GL-0901
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 6

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.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment

  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

  0, 4, 8, 12 and 16 weeks after the injection

• Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment

  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

  0, 4, 8, 12 and 16 weeks after the injection

• Glabellar line improvement rate confirmed with subject's assessment

  4, 8, 12 and 16 weeks after the injection

Study Arms (2)

Botulinum toxin type A(Meditoxin®)

EXPERIMENTAL

Drug: Botulinum Toxin Type A(Meditoxin®)

Botulinum toxin type A(Botox®)

ACTIVE COMPARATOR

Drug: Botulinum Toxin Type A(Botox®)

Interventions

Botulinum Toxin Type A(Meditoxin®) DRUG

single administration, Day 0, 20U

Also known as: Neuronox®, Siax®

Botulinum toxin type A(Meditoxin®)

Botulinum Toxin Type A(Botox®) DRUG

single administration, Day 0, 20U

Botulinum toxin type A(Botox®)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (6)

Seoul National University Bundang Hospital

Seongnam-si, Gyoung-gi Do, 463-707, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, 110-746, South Korea

Location

Sevrance Medical Center

Seoul, 120-749, South Korea

Location

St. Paul Hospital

Seoul, 130-709, South Korea

Location

Seoul Asan Medical Center

Seoul, 138-736, South Korea

Location

Chung-Ang University Yong-San Hospital

Seoul, 140-013, South Korea

Location

Related 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(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62.

  PMID: 12973229 RESULT

• 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.

  PMID: 19416246 RESULT

• 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.

  PMID: 9463853 RESULT

• 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.

  PMID: 884196 RESULT

MeSH Terms

Interventions

Botulinum Toxins, Type A; 3-deoxyglycero-galacto-nonulosonic acid

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Chang-Hun Huh, MD, Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Hoon Kang, MD, Ph.D.

  St. Paul Hospital

  PRINCIPAL INVESTIGATOR

• Won-Seok Kim, MD, Ph.D.

  Kang-Buk Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Jong-Hyun Won, MD, Ph.D.

  Seoul Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Joo-Hee Lee, MD, Ph.D.

  Sevrance Medical Center

  PRINCIPAL INVESTIGATOR

• Beom-Joon Kim, MD, Ph.D.

  Chung-Ang University Yong-San Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 10, 2010
• Study Start: November 23, 2009
• Primary Completion: August 30, 2010
• Study Completion: September 30, 2010
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

KR (6)