Condition or disease | Intervention/treatment | Phase |
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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:
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) |
Actual Enrollment : | 355 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Primary Completion Date : | March 15, 2020 |
Actual Study Completion Date : | December 22, 2020 |
Arm | Intervention/treatment |
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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.
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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
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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.
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Drug: Placebo
injection, sodium chloride 0.9 % divided in five 0.1 mL i.m injections into the glabellar area
Other Name: sodium chloride 0,9 %
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Tennessee Clinical Research Center | |
Nashville, Tennessee, United States, 37215 |
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) |
Tracking Information | ||||||||||||||||||||||
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First Submitted Date ICMJE | June 12, 2019 | |||||||||||||||||||||
First Posted Date ICMJE | June 14, 2019 | |||||||||||||||||||||
Last Update Posted Date | May 19, 2021 | |||||||||||||||||||||
Actual Study Start Date ICMJE | April 29, 2019 | |||||||||||||||||||||
Actual Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||
Change History | ||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||
Brief Title ICMJE | Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII) | |||||||||||||||||||||
Official Title ICMJE | 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 | |||||||||||||||||||||
Brief 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. | |||||||||||||||||||||
Detailed Description |
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:
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. |
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Study Type ICMJE | Interventional | |||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Glabellar Frown Lines | |||||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||
Actual Enrollment ICMJE |
355 | |||||||||||||||||||||
Original Estimated Enrollment ICMJE |
353 | |||||||||||||||||||||
Actual Study Completion Date ICMJE | December 22, 2020 | |||||||||||||||||||||
Actual Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
Listed Location Countries ICMJE | United States | |||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||
NCT Number ICMJE | NCT03985982 | |||||||||||||||||||||
Other Study ID Numbers ICMJE | CPH-303-201400 | |||||||||||||||||||||
Has Data Monitoring Committee | No | |||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Croma-Pharma GmbH | |||||||||||||||||||||
Study Sponsor ICMJE | Croma-Pharma GmbH | |||||||||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Croma-Pharma GmbH | |||||||||||||||||||||
Verification Date | February 2021 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |