Safety and Efficacy Study of Dysport RU® and Glabellar Lines - Full Text View

Purpose

The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.

Condition	Intervention	Phase
Glabellar Frown Lines	Drug: Botulinum type A toxin (Dysport RU®) Drug: Botulinum type A toxin (Azzalure®) Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

The proportion of responders in the Investigator's live assessment (using validated 4-point photographic scale) and the subject's self-assessment [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects assessed as responders, by both Investigator's live assessment and the subject's self-assessment at maximum frown. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
The proportion of responders at maximum frown as measured by the Investigator's live assessment. [ Time Frame: Days 8, 15, 57, 85 and 113 ] [ Designated as safety issue: No ]
The proportion of subjects, assessed as responders, by both the Investigator's live assessment and the subject's self-assessment at maximum frown. [ Time Frame: Days 8, 15, 57, 85 and 113 ] [ Designated as safety issue: No ]
The proportion of responders at rest as measured by the Investigator's live assessment. [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
The proportion of responders at maximum frown on Day 29 who remain responders. [ Time Frame: Day 113 ] [ Designated as safety issue: No ]
The proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown 2 as measured by the Investigator's live assessment. [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
The proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at rest as measured by the Investigator's live assessment. [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
The proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown as measured by the subject's self-assessment. [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
The proportion of responders at maximum frown as measured by the subject's self-assessment. [ Time Frame: Days 8, 15, 57, 85 and 113 ] [ Designated as safety issue: No ]

Enrollment:	176
Study Start Date:	March 2011
Study Completion Date:	September 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dysport RU 20 U	Drug: Botulinum type A toxin (Dysport RU®) I.M. (in the muscle) injection on day 1 (single treatment cycle)
Experimental: Dysport RU 50 U	Drug: Botulinum type A toxin (Dysport RU®) I.M. (in the muscle) injection on day 1 (single treatment cycle)
Experimental: Dysport RU 75 U	Drug: Botulinum type A toxin (Dysport RU®) I.M. (in the muscle) injection on day 1 (single treatment cycle)
Active Comparator: Dysport (Azzalure) 50 U	Drug: Botulinum type A toxin (Azzalure®) I.M. on day 1 (single treatment cycle)
Placebo Comparator: Placebo	Drug: Placebo I.M. on day 1 (single treatment cycle)

Eligibility

Ages Eligible for Study:	30 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female between 30 - 55 years of age
Moderate to severe vertical glabellar lines at maximum frown at baseline

Exclusion Criteria:

Silicone injections into the upper face
Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or photorejuvenation within the previous 12 months
Any planned facial cosmetic surgery during the study period
A history of ablative skin resurfacing of the area to be treated during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333397

Locations

France
Private practice
Bordeaux, France
Private practice
Cannes, France
Private practice
Juan Les Pins, France
Private practice
Paris, France
Germany
Charité hospital
Berlin, Germany
Private clinic
Dresden, Germany
Private clinic
Munich, Germany
Private clinic
Starnberg, Germany

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Ipsen Study Director

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT01333397 History of Changes
Other Study ID Numbers:	Y-52-52120-146, 2010-019085-82
Study First Received:	April 8, 2011
Last Updated:	November 22, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013