Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II (BLESS-II)

Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo Followed by an Open Label Extension Study

The aim of this study is to assess the efficacy and safety of BoNT/a-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: Botulinum Toxin A; Drug: Placebo; Drug: Botulinum Toxin A - Open Label

Detailed Description

This multicenter Phase 3 study is comprised of two parts. The first part of the study is a randomized, double blind, placebo-controlled, phase which aims to demonstrate efficacy and safety of BoNT/A-DP compared with placebo. The second part is an open label extension phase to evaluate efficacy after repeat treatments and long term safety. Subjects can receive a maximum of four treatment cycles over the duration of the study, a single treatment in the first cycle compared with placebo, and up to three subsequent treatments in the open label extension study.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged ≥ 18 years or older at time of screening
• Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as determined by in-clinic assessments by both the investigator and the subject(where: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe').

Exclusion Criteria:

• Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.
• Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to screening, or any planned treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment).
• Active skin disease/infection or irritation at the treatment area.
• Pregnant, breastfeeding or planning to become pregnant during the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum toxin A; Botulinum Toxin A will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into glabellar area.	Drug: Botulinum Toxin A; Injection, 20 Units divided in five 0.1mL i.m injections into the glabellar area; Other Names: BoNT/A-DP
Placebo Comparator: Placebo; Placebo will be administered in double blind fashion in cycle 1 divided in five 0.1 mL injections into the glabellar area.	Drug: Placebo; injection, sodium chloride 0.9% divided in five 0.1 mL i.m. injections into the glabellar area; Other Names: sodium chloride 0.9 %
Experimental: Botulinum toxin A open label extension phase; Open Label Extension Phase for all Subjects of Arm 1 and 2 for up to 3 treatment cycles	Drug: Botulinum Toxin A - Open Label; Open Label Extension Phase with Experimental Drug; Injection, 20 Units divided in five 0.1mL i.m injections into the glabellar area; Other Names: BoNT/A-DP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate at Week 4	Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators'and the subjects'in-clinic assessments.	week 4 relative to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of responders at maximum frown at week 12	Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement ≥2 points in FWS score (at maximum frown) at the week 12 visit relative to baseline, based on both the investigator's and the subject's in-clinic assessment	week 12
Percentage of responders at week 16	Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement ≥2 points in FWS score (at maximum frown) at the week 16 visit relative to baseline, based on both the investigator's and the subject's in-clinic assessment	week 16
Subjects with a ≥ 1 point reduction in FWS score	The proportion of subjects with a ≥ 1 point reduction in FWS score at rest at week 4 based separately on the investigators'and the subjects'in-clinic assessments	week 4
Percentage of responders at week 20 or later	Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement ≥2 points in FWS score (at maximum frown) at the week 20 visit (or later) relative to baseline, based on both the investigator's and the subject's in-clinic assessment	week 20
Safety Evaluation	Frequency, severity and causal relationship of AEs, SAes and AESIs	trough study completion (60 weeks)

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2016
• Primary Completion (Actual): September 15, 2016
• Study Completion (Actual): November 3, 2017

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: CPH-302-201030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No