Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2021-02-01

Brief Summary

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The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.

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Detailed Description

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This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada.

To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing commercially available product (Botox Cosmetic).

Two hundred subjects will be enrolled, which should allow for a precise estimate of response rate and for post-hoc sensitivity analyses.

The duration of study participation for each subject will be up to 18 weeks, to include screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200 subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and subjects will be blinded to treatment. Investigators and subjects will evaluate the severity of glabellar lines independently.

Conditions

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Frown Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. The benefit of participation in this study is the expected reduction in the severity of glabellar frown lines. All subjects will benefit from free medical screenings and follow up.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Eligible subjects will be randomized at Baseline (Day 0) to Group A or B in a 1:1 randomization scheme. Investigators and subjects will be blinded to the treatment administered and will evaluate the severity of glabellar lines independently. The subjects should perform their assessment independently and ideally before the investigator, to ensure they are not biased by the investigator. The same investigator must complete the Baseline assessments and FWS at Week 4 (primary endpoint assessments) for a given subject.

Study Groups

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Group A (n=100): BoNT/A-DP (20 U, 0.5 mL)

The injection sites should be prepared according to standard clinical procedures..

A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.

Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).

Group Type ACTIVE_COMPARATOR

Botulinum toxin A "BoNT/A-DP"

Intervention Type BIOLOGICAL

To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.

Group B (n=100): Botox Cosmetic (20 U, 0.5 mL)

The injection sites should be prepared according to standard clinical procedures.

A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.

Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).

Group Type ACTIVE_COMPARATOR

Botulinum toxin A "Botox Cosmetics"

Intervention Type BIOLOGICAL

To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.

Interventions

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Botulinum toxin A "BoNT/A-DP"

To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.

Intervention Type BIOLOGICAL

Botulinum toxin A "Botox Cosmetics"

To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject has a stable medical condition with no uncontrolled systemic disease.
* Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study.
* Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the GLS-S), without glasses obstructing the forehead area.

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 either study medication 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 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.
* Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the three months prior to Screening or planned during the study.

o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo rejuvenation) within 12 months prior to Screening or planned during the study.
* Previous insertion of permanent material in the glabellar area, or planned insertion during the study.
* Any planned or history of surgery in the glabellar area and/or canthal line area, or scars in the glabellar and/or canthal line.
* Active skin disease/infection or irritation at the treatment area.
* Inability to substantially lessen glabellar frown lines and or lateral canthal lines even by physically spreading them apart.
* Use of a muscle relaxant within 2 weeks prior to Screening, or planned use during the study.
* Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator.
* Pregnant, breastfeeding or planning to become pregnant during the study.
* Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to Screening or planned during the study.
* Planned surgery with general anesthetic (use of local anesthetic outside the glabellar area is permitted).
* Participation in another clinical study within one month of Screening and throughout the study.
* Previous participation in another botulinum toxin aesthetic study, which involved the treatment of glabellar, lines in combination with canthal lines and/or forehead lines in the previous 18 months.
* Chronic drug or alcohol abuse (as per investigator discretion).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No