Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines

NCT ID: NCT00512135

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 801 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-18
• Study Completion Date: 2009-12-28

Brief Summary

The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.

Detailed Description

This was a prospective, multicenter, open-label, non-control group design Phase 3 clinical study. Approximately 880 participants who were to complete former studies in this program (370 participants from studies MRZ 60201-0520/1 (8) and MRZ 60201-0527/1 (8) as well as approximately 510 participants from studies MRZ 60201-0724/1 (10) and MRZ 60201-0741/1) (11) were expected to enroll in this study in 26 centers in the United States, Canada and Germany. Participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of these four "feeder" studies in the frown line program were eligible to participate in this repeated dose study. Each participant received a dose of 20 units incobotulinumtoxinA (Xeomin) intramuscular injection on Visit 1 (Day 0 of Cycle 1). Re-injections with 20 U NT 201 could be performed on Day 0 of a subsequent cycle for up to 8 cycles (one cycle >= 85 days). Intervals between treatments were at least three months or 12 weeks, i.e., >= 85 days. For a new treatment cycle to start, the participant had to request a re-injection. The investigator then had to assess if the glabellar frown lines had relapsed to 'moderate' or 'severe'. In this case, a new injection could be administered. The treatment duration per participant was 24 months and up to eight cycles for participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 and 6 months and up to two cycles for participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1, respectively. Participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 participated at least one year in the study whereas participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1 participated for six months and up to two cycles.

Conditions

Glabellar Lines

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IncobotulinumtoxinA (Xeomin) (20 units)

IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection

Group Type: EXPERIMENTAL

IncobotulinumtoxinA (Xeomin) (20 units)

Intervention Type: DRUG

Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.

Interventions

IncobotulinumtoxinA (Xeomin) (20 units)

Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.

Intervention Type: DRUG

Other Intervention Names

IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins (20 units)

Eligibility Criteria

Inclusion Criteria

Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the beginning of each treatment cycle (as assessed by the investigator according to FWS) , stable medical condition; Completion of one former study in the Merz NT 201 glabellar program

Exclusion Criteria

Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo rejuvenation) in the glabellar area during the last 12 months, Previous insertion of permanent material in the glabellar area; Planned treatment with Botulinum toxin of any serotype in any body region during the study period, Any other planned facial aesthetic procedure in the glabellar area during the trial period; Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these or scars in the glabellar area, Inability to substantially lessen glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis of eyelid and/or eyebrow; Any infection in the area of the injection sites.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berthold Rzany, Prof. Dr. med Sc.M.

Role: PRINCIPAL_INVESTIGATOR

Division of Evidence Based Medicine dEBM, Department of Dermatology, Venerology and Allergology , Charité - University Medicine, Berlin, Germany

Timothy Corcoran Flynn, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Skin Care Centre

Los Angeles, California, United States

About Skin Dermatology

Englewood, Colorado, United States

Centre for Cosmetic Enhancement

Aventura, Florida, United States

Brandt

Coral Gables, Florida, United States

Advanced Dermatology Research Institute

Lincolnshire, Illinois, United States

Laser &Skin Surgery Center of Indiana

Carmel, Indiana, United States

Coleman

Metairie, Louisiana, United States

Skin Care Physisians of Chestnut Hill

Chestnut Hill, Massachusetts, United States

Schlessinger

Omaha, Nebraska, United States

Image Dermatology P.C.

Montclair, New Jersey, United States

Narins

White Plains, New York, United States

Flynn Consulting PLLC

Raleigh, North Carolina, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Carruthers Dermatology Centre Inc.

Vancouver, British Columbia, Canada

Solish

Toronto, Ontario, Canada

Charité Berlin - Klinik für Dermatologie

Berlin, , Germany

Rosenparkklinik

Darmstadt, , Germany

Krankenhaus Dresden Friedrichstadt

Dresden, , Germany

Johann-Wolfgang-Goethe- Universitätsklinikum Frankfurt

Frankfurt am Main, , Germany

Universität Hamburg

Hamburg, , Germany

SCIderm GmbH

Hamburg, , Germany

Uniklinik Saarland

Homburg / Saar, , Germany

Dr. Michael Sebastian

Mahlow, , Germany

Dr. Hans-Ulrich Voigt

München, , Germany

Dr. Thomas Dirschka

Wuppertal, , Germany

Countries

United States; Canada; Germany

References

Rzany B, Flynn TC, Schlobe A, Heinz M, Harrington L. Long-term results for incobotulinumtoxinA in the treatment of glabellar frown lines. Dermatol Surg. 2013 Jan;39(1 Pt 1):95-103. doi: 10.1111/dsu.12008. Epub 2012 Nov 27.

Reference Type: RESULT

PMID: 23190342 (View on PubMed)

Other Identifiers

2006-005342-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ 60201-0609/1

Identifier Type: -

Identifier Source: org_study_id