Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII) (NCT03985982) | Clinical Trial Compass
CompletedPhase 3
Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII)
United States410 participantsStarted 2019-04-29
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages ā„ 18 years or older at time of screening (upper limit 75 years, inclusive).
* 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“).
Subject had a stable medical condition with no uncontrolled systemic disease.
* Female subjects of childbearing potential had to test negative for pregnancy and agree to use effective birth control during the course of the study.
* Subjects who wear glasses had to be able to adequately self-assess the severity of their glabellar lines (according to the FWS), without glasses obstructing the forehead area.
* Moderate to severe glabellar lines indicating an important psychological impact on the subject as indicated by scores \> 0 on either the Emotional or the Social Functioning subscale of the Modified Skindex-16 GL-QoL scale.
Exclusion Criteria:
* 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 study (other than the investigational treatment).
* Known hypersensitivity to the study drug or its excipients.
* 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 lateā¦
What they're measuring
1
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.