Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESS III) (BLESS III)
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|ClinicalTrials.gov Identifier: NCT03985982|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glabellar Frown Lines||Drug: Botulinum Toxin A Drug: Placebo||Phase 3|
The study is a parallel-group, randomized, double blind, placebo-controlled study followed by an open label extension.
An interim Analysis will be performed when all subjects finalized the re-evaluation for retreatment visit at week 16 of the first treatment cycle or completed the double blind phase (whichever occurs earlier).
The first treatment cycle of the study will comprise two treatment groups as follows:
- Group A (active): BoNT/A-DP (20 units, 0.5 mL)
- Group B (placebo control): sterile, 0.9% sodium chloride, (0.5 mL). Eligible subjects will be randomized at baseline (day 0) to Group A or B to receive the first treatment in a 3:1 randomization scheme, respectively. Investigators and subjects will be blinded to the treatment administered and will evaluate the severity of glabellar lines independently. The subject should perform their assessment independently and ideally before the investigator, to ensure they are not biased by the investigator. The same investigator should assess the subject at baseline and at the visits at weeks 1, 2 and 4 in the first treatment cycle.
After a screening period of up to14 calendar days, subjects will receive the first treatment (BoNT/A-DP or placebo) and attend for visits at 1, 2 and 4 weeks after treatment and at 4 weekly intervals thereafter for evaluation of efficacy and safety (primary and key secondary efficacy endpoints are evaluated in the first treatment cycle in comparison with placebo).
The first treatment cycle will last at least 12 weeks and will end when the subjects qualify for re-treatment (in accordance with the "eligibility for re-treatment criteria"). After the first treatment cycle is completed, all subjects may enter the open label extension phase and will be dosed with BoNT/A-DP (20 U) for subsequent re-treatments.
Evaluation for re-treatment takes place at the earliest at 12 weeks after the first/previous treatment. Subjects who do not qualify for re-treatment at week 12 will have the option (pending eligibility) of re-treatment at a later visit (at 4 weekly intervals thereafter) until they are eligible for re-treatment or until a total of 48 weeks has elapsed since study start. Subjects will attend for visits at 1 and 4 weeks after any re-treatment and at 4 weekly intervals thereafter. At week 2 and week 8 of each open label cycle a telephone call visist will take place. According to the study schedule (Section 2.1 and Section 2.2), a maximum of 4 treatments per subject (4 treatment cycles) is permitted during the study time frame, with treatments separated by a minimum of 12 weeks.
The number of treatments administered per subject will depend on the subject's qualification for re-treatment; however, the last opportunity for re-treatment is at week 48.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||353 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||April 29, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
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 0.1 mL i.m injections into the glabellar area
Other Name: 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.
injection, sodium chloride 0.9 % divided in five 0.1 mL i.m injections into the glabellar area
Other Name: sodium chloride 0,9 %
- 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. [ Time Frame: week 4 relative to baseline ]The primary endpoint is the proportion of subjects among BoNT/A-DP and placebo groups with a 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 (of the first treatment cycle) relative to baseline (responders), based on both the investigators'and the subjects'in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness.
- Percentage of responders at maximum frown at week 12 [ Time Frame: week 12 ]The percentage of responders at maximum frown at week 12 (after the first treatment with BoNT/A-DP or placebo).
- Percentage of responders at week 16 [ Time Frame: week 16 ]The percentage of responders at week 16 (after the first treatment).
- The proportion of subjects with a ≥ 1 point reduction in FWS score at rest at week 4 based separately on the investogators´and the subjects´ in-clinic assessments [ Time Frame: week 4 ]3. The proportion of subjects with a ≥ 1 point reduction in FWS score at rest at week 4 in the first treatment cycle, based separately on the investigators'and the subjects'in-clinic assessments (applicable only for subjects who have a FWS score at rest ≥ 1 at baseline).
- Percentage of responders at week 20 or up to week 48 [ Time Frame: week 20 ]The percentage of responders at week 20 or up to week 48 (after the first treatment)
- Frequency, severity and causal relationship of AEs, SAes and AESIs [ Time Frame: through study completion (60 weeks) ]Frequency, severity and causal relationship of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the entire study period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985982
|Contact: Sonja Höller, PhDfirstname.lastname@example.org|
|Contact: Marion Pucher, Dr.||+email@example.com|
|United States, Tennessee|
|Tennessee Clinical Research Center||Recruiting|
|Nashville, Tennessee, United States, 37215|
|Contact: Michael Gold|
|Principal Investigator:||Jeffrey Adelglass, Dr.||SKINTASTIC Medical|
|Principal Investigator:||Sue Ellen Cox, Dr.||Aesthetic Solutions P.A.|
|Principal Investigator:||Michael Gold, Dr.||Tennessee Clinical Research Center|
|Principal Investigator:||Joely Kaufman-Janette, Dr.||Skin Research Institute LLC|
|Principal Investigator:||Susan Taylor, Dr.||Perelman Center for Advanced Medicine-University of Pennsylvania|
|Principal Investigator:||Mark Nestor, Dr.||Center for Clinical and Cosmetic Research|
|Principal Investigator:||Daniel Mueller, Dr.||Yuvell (Austria)|