Dysport in the Treatment of Glabellar Lines in Chinese Subjects

NCT02450526 | Completed Phase 3 Results

• 1 other identifier: Y-52-52120-158
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 10

Brief Summary

The objective of this study is to demonstrate the efficacy of Dysport for the improvement in appearance of moderate to severe glabellar lines and to assess the short term and long term safety of Dysport, used for the improvement in appearance of moderate to severe glabellar lines in Chinese subjects.

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (3)

• Superiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).

  At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline. Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.

  At Cycle 1, Day 29.

• Superiority Analysis of The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1, Day 29 (DB Period).

  At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, subjects assessed the appearance of their glabellar lines at maximum frown using a 4-point categorical scale. The 4-point scale represents the severity of glabellar lines as Grade 0 (no wrinkles), Grade 1 (mild wrinkles), Grade 2 (moderate wrinkles) and Grade 3 (severe wrinkles). For the SSA, a responder was defined as having a severity grade of 0 or 1 at maximum frown at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline. Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.

  At Cycle 1, Day 29.

• Non-Inferiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).

  At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline. Non Inferiority analysis of Dysport® versus Botox was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.

  At Cycle 1, Day 29.

Secondary Outcomes (3)

• The Percentage of Responders With Respect to Independent Reviewer's Assessment of Photographs of the Subject's Glabellar Lines at Maximum Frown at Cycle 1, Day 29 (DB Period).

  At Cycle 1, Day 29.

• Mean Subject's Global Assessment (SGA) Score at Cycle 1, Day 29 (DB Period).

  At Cycle 1, Day 29.

• The Percentage of Responders With Respect to the SGA Score at Cycle 1, Day 29 (DB Period).

  At Cycle 1, Day 29.

Other Outcomes (14)

• The Percentage of Responders Measured by the ILA at Maximum Frown at Cycle 1 Study Visits (DB Period).

  Up to Cycle 1, Day 85.

• The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1 Study Visits (DB Period).

  Up to Cycle 1, Day 85.

• The Percentage of Responders Measured by the ILA at Rest at Cycle 1 Study Visits (DB Period).

  Up to Cycle 1, Day 85.

Study Arms (4)

AbobotulinumtoxinA

EXPERIMENTAL

Dysport, 50 Units, divided into five injections into the glabellar area. Administered in double blind fashion at cycle 1 followed by up to 4 cycles Dysport, 50 Units administered with an interval period depending on response, no less than 12 weeks between each treatment cycle.

Biological: Botulinum toxin type A

OnabotulinumtoxinA

ACTIVE COMPARATOR

Botox will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.

Biological: Botulinum toxin type A

AbobotulinumtoxinA Placebo

PLACEBO COMPARATOR

Dysport placebo will be administered in treatment cycle 1 only. On Day 1, 50 Units, divided into five injections into the glabellar area.

Drug: Placebo

OnabotulinumtoxinA Placebo

PLACEBO COMPARATOR

Botox placebo will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.

Drug: Placebo

Interventions

Botulinum toxin type A BIOLOGICAL

Also known as: AbobotulinumtoxinA (Dysport®)

AbobotulinumtoxinA

Placebo DRUG

50 Units

AbobotulinumtoxinA Placebo

Eligibility Criteria

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

You may qualify if:

• Provision of written informed consent
• Male or female Chinese subjects who are between 18 to 65 years of age inclusive.
• Have moderate or severe wrinkles of vertical glabellar lines (Grade 2 or 3) at maximum frown at baseline (Day 1), as assessed by the subject using SSA.
• Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at baseline (Day 1), as assessed by the Investigator using ILA.
• Be Botulinum Toxin (BTX) naïve or have received their most recent BTX-A treatment more than 1 year prior to screening.
• Have a negative pregnancy test
• Have an understanding of the study

You may not qualify if:

• Any prior surgery affecting corrugator supercilii, prior blepharoplasty or brow lift, dermal resurfacing, or any prior cosmetic procedures or scars within 36 months.
• Any prior treatment with permanent fillers in the upper face.
• Any prior treatment with nonpermanent dermal fillers in the upper face within the past 3 years and/or skin abrasions/resurfacing, photorejuvenation or skin/vascular laser intervention within the past 12 months.
• Any planned facial cosmetic surgery or procedures during the study period.
• Lack of capacity to frown.
• Facial conditions that could affect safety or efficacy results.
• History of facial nerve palsy.
• Marked asymmetry; ptosis; excessive dermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc.
• Presence of any condition that could affect the safety, conduct or outcome of the study.
• Any subjects who have any psychiatric illness or are taking antidepressant, anxiolytic or antipsychotic medication.
• Pregnant and/or lactating female subjects.
• Female subjects of childbearing potential not willing to use contraceptive measures throughout the course of the study.
• History of drug or alcohol abuse.
• Treatment with an experimental drug or device within 30 days prior to screening for this study and during the conduct of this study.
• Requirement for BTX injection to site(s) for disorders other than glabellar lines.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

Peking University First Hospital

Beijing, 100034, China

Location

Air Force General Hospital, PLA

Beijing, 100142, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

The Third Xiangya Hospital of Central South University

Changsha, 410013, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guanzhou, 510630, China

Location

Dermatology Hospital of the Chinese Academy of Medical Sciences

Nanjing, 210042, China

Location

Tianjin Medical University General Hospital

Tianjing, 300052, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022, China

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

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

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

Study Officials

• Ipsen Study Director, M.D.

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 6, 2017
• Last Updated: August 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-07

Locations

CN (10)