The purpose of this clinical study is to assess safety and efficacy of different doses of Dysport® RU (RU= Ready to Use), a new formulation of a drug called Dysport®, which is used for the improvement in the appearance of glabellar lines (lines that appear on the forehead between the eyebrows). Additionally, the study will aim to establish the dose of Dysport® RU, which is equivalent in terms of safety and efficacy to the optimal dose of 50 U of Dysport®.

• Register: EUCTR
• Last refreshed on: 21 January 2013
• Main ID: EUCTR2010-019085-82-DE
• Date of registration: 27/12/2010
• Prospective Registration: Yes
• Primary sponsor: Ipsen Innovation
• Public title: The purpose of this clinical study is to assess safety and efficacy of different doses of Dysport® RU (RU= Ready to Use), a new formulation of a drug called Dysport®, which is used for the improvement in the appearance of glabellar lines (lines that appear on the forehead between the eyebrows). Additionally, the study will aim to establish the dose of Dysport® RU, which is equivalent in terms of safety and efficacy to the optimal dose of 50 U of Dysport®.
• Scientific title: A PHASE II, DOUBLE BLIND, RANDOMISED, PLACEBO AND ACTIVE COMPARATOR CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF THREE DOSES OF DYSPORT RU (20 U, 50 U AND 75 U) ADMINISTERED AS A SINGLE TREATMENT CYCLE TO IMPROVE THE APPEARANCE OF MODERATE TO SEVERE GLABELLAR LINES
• Date of first enrolment: 24/02/2011
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019085-82
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 5

Countries of recruitment

Germany

Contacts

• Name: Not applicable
• Affiliation: Ipsen Innovation

• Name: Not applicable
• Affiliation: Ipsen Innovation

Key inclusion & exclusion criteria

Inclusion criteria:
(1) Provision of written informed consent prior to any study related procedures. (2) Be female between 30 and 60 years of age, inclusive. (3) Have moderate to severe vertical glabellar lines at maximum frown at Day 1 (baseline, pre-treatment), as assessed by the Investigator’s and subject’s assessment using a validated 4-point Photographic Scale. (4) Be naïve to previous treatment with any serotype of BTX. (5) Have a negative pregnancy test (for females of childbearing potential only). Nonchildbearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation at least three months before entering screening, or hysterectomy. (6) Have both the time and ability to complete the study and comply with study instructions. (7) Have an understanding of the study and the contents of the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
(1) Previous treatment with any serotype of BTX. (2) A history of silicone injections into upper face within the previous 5 years. (3) Any prior treatment with permanent or semi-permanent dermal fillers in the glabellar region within the previous 5 years and/or skin abrasions or photorejuvenation within the previous 12 months. (4) Any planned facial cosmetic surgery during the study period. (5) A history of ablative skin resurfacing of the area to be treated during the study. (6) A history of upper eyelid blepharoplasty or brow lift within the previous 5 years. (7) An inability to substantially reduce glabellar lines by physically spreading them apart. (8) An active infection or other skin problem in the glabellar area (e.g. acute acne lesions or ulcers). (9) Concurrent therapy which, in the Investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study treatment. (10) Pregnant women, nursing mothers, or women who are planning a pregnancy during the study, or think they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use a reliable form of contraception (e.g. oral contraceptives for more than 12 consecutive weeks, or spermicide and condoms). (11) A history of chronic drug or alcohol abuse. (12) Receipt of any experimental drug or use of any experimental device within 30 days prior to the start of the study and during the conduct of the study. (13) Known allergy or hypersensitivity to any serotype of BTX or any component of Dysport RU or Dysport. (14) Clinically diagnosed anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject’s participation in the study. (15) Use of medications that affect neuromuscular transmission, such as curare-like nondepolarizing agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics. (16) A history of facial nerve palsy. (17) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin. (18) Presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgment of the Investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Moderate to severe glabellar lines
MedDRA version: 13.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Intervention(s)

Product Name: Dysport RU
Product Code: Dysport RU
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Trade Name: Azzalure
Product Name: Azzalure
Product Code: Not applicable
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: D29

Secondary Objective: The secondary objective is to assess the relative safety and efficacy of Dysport RU compared to Dysport when used for the improvement in appearance of moderate to severe glabellar lines.

Main Objective: The primary objective is to assess the dose response versus placebo of a single treatment with Dysport RU used for the improvement in the appearance of moderate to severe glabellar lines at maximum frown.

Primary end point(s): The co-primary efficacy endpoints for this study will be the proportion of responders at Day 29 in the Investigator’s live assessment of glabellar lines at maximum frown and the subject’s self-assessment of glabellar lines at maximum frown.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Days 8, 15, 29, 57, 85 and 113

Secondary end point(s): • The proportion of subjects, assessed as responders on Day 29, by
both the Investigator’s live assessment and the subject’s
self-assessment at maximum frown.
• The proportion of responders at maximum frown on Days 8, 15,
57, 85 and 113 as measured by the Investigator’s live assessment.
• The proportion of responders at maximum frown on Days 8, 15,
57, 85 and 113 as measured by the subject’s self-assessment.
• The proportion of subjects, assessed as responders on Days 8, 15,
57, 85 and 113, by both the Investigator’s live assessment and the
subject’s self-assessment at maximum frown.
• The proportion of responders at rest on Days 8, 15, 29, 57, 85 and
113 as measured by the Investigator’s live assessment.
• The proportion of responders at maximum frown on Day 29 who
remain responders on Day 113.
• The proportion of subjects with a reduction of two or more grades
in the severity of glabellar lines at maximum frown (e.g. change
from baseline severity of glabellar lines from 3 (severe) to
1 (mild) or from baseline severity of 2 (moderate) to 0 (none)
after treatment) on Days 8, 15, 29, 57, 85 and 113 as measured by
the Investigator’s live assessment.
• The proportion of subjects with a reduction of two or more grades
in the severity of glabellar lines at rest (e.g. change from baseline
severity of glabellar lines from 3 (severe) to 1 (mild) or from
baseline severity of 2 (moderate) to 0 (none) after treatment) on
Days 8, 15, 29, 57, 85 and 113 as measured by the Investigator’s
live assessment.
• The proportion of subjects with a reduction of two or more grades
in the severity of glabellar lines at maximum frown (e.g. change
from baseline severity of glabellar lines from 3 (severe) to
1 (mild) or from baseline severity of 2 (moderate) to 0 (none)
after treatment) on Days 8, 15, 29, 57, 85 and 113 as measured by
the subject’s self-assessment.

Secondary ID(s)

Y-52-52120-146

Source(s) of Monetary Support

Ipsen Innovation