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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
Sponsor:
Information provided by (Responsible Party):
Croma-Pharma GmbH

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.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Drug: Botulinum Toxin A Drug: Placebo Phase 3

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:

  • 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 353 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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 0.1 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.
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 %




Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  1. 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).

  2. Percentage of responders at week 16 [ Time Frame: week 16 ]
    The percentage of responders at week 16 (after the first treatment).

  3. 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).

  4. 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)

  5. 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.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Ages ≥ 18 years or older at time of screening
  • Has moderate to severe glabellar fown lines at maximum frown (severity score of 2 or 3 on FWS) as determinated 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 inivestigator´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 trail (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985982


Contacts
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Contact: Sonja Höller, PhD +43-2262-684-686-0 sonja.hoeller@croma.at
Contact: Marion Pucher, Dr. +43-2262-684-686-0 marion.pucher@croma.at

Locations
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United States, Tennessee
Tennessee Clinical Research Center Recruiting
Nashville, Tennessee, United States, 37215
Contact: Michael Gold         
Sponsors and Collaborators
Croma-Pharma GmbH
Investigators
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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)

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Responsible Party: Croma-Pharma GmbH
ClinicalTrials.gov Identifier: NCT03985982     History of Changes
Other Study ID Numbers: CPH-303-201400
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is not decided yet and will be changed accordingly when the decision has been made

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents