Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II

Glabellar Frown Lines Clinical Trial

— BLESS-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677805
• Other study ID #: CPH-302-201030
• Status: Completed
• Phase: Phase 3
• Start date: March 30, 2016
• Est. completion date: November 3, 2017

Study information

• Verified date: May 2022
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 3, 2017
• Est. primary completion date: September 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• Botulinum Toxin A
Injection, 20 Units divided in five 0.1mL i.m injections into the glabellar area
• Placebo
injection, sodium chloride 0.9% divided in five 0.1 mL i.m. injections into the glabellar area
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Croma-Pharma GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety Evaluation	Frequency, severity and causal relationship of AEs, SAes and AESIs	trough study completion (60 weeks)