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| Name | Class |
|---|---|
| Hugel | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) | Active Comparator | 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 B (n=100): Botox Cosmetic (20 U, 0.5 mL) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A "BoNT/A-DP" | Biological | To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 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. | The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 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. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders. | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. |
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Inclusion Criteria:• Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on GLS-I/GLS-S) as determined by in clinic assessments by both the investigator and the subject (where: 0='none', 1='mild', 2='moderate', 3='severe').
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATS Clinical Research | Santa Monica | California | 90404 | United States | ||
| Skin Research Institute LLC |
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Of 208 enrolled participants, 200 met inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. |
| FG001 | 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). 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: 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). 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 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. | The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 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. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders. | The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4. | Posted | Count of Participants | Participants | week 4 |
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corona virus infection | Infections and infestations | MedDRA (22.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development - Head of Clinical Operations | Croma Pharma GmbH | +43 2262 684680 | clinical.studies@croma.at |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2019 | Nov 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2021 | Nov 28, 2024 | SAP_001.pdf |
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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.
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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.
| Botulinum toxin A "Botox Cosmetics" | Biological | To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown. |
|
| Weeks 1, 2, 8, 12 and 16 |
| Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 2 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. | Weeks 1, 2, 4, 8, 12 and 16 |
| Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at rest over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. | Weeks 1, 2, 4, 8, 12 and 16 |
| Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment | Time to onset of effect in days, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Onset of effect is defined as at least 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale - Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. GLS-I and GLS-S both use the same 4-point scale, ranked as 0 (No lines/minimal lines), 1 (Mild lines), 2 (Moderate lines) and 3 (Severe lines). | From treatment at Day 0 to Week 4 |
| Duration of Effect Based on Independent Investigator Assessment and Subject Assessment | For subjects who are responders at week 4, duration of effect in days is assessed based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Effect is deemed to be lost when scores return to Baseline or worse values. Duration of effect is defined as (the date that loss of response occurred) - (date of single study treatment ) + 1. | 16 Weeks |
| FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Summary of FACE-Q satisfaction with outcome scale based on subject assessment at weeks 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." | Weeks 4, 12 and 16 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Frequency, seriousness and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest (AESIs), as well as causal relationship to the study medication and the study procedure, during the entire study period. A subject with multiple occurrences of an adverse event is counted only once within the worst severity category. | through study completion, an average of 16 weeks |
| Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Summary of change from baseline in diastolic/systolic blood pressure at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. | Weeks 1, 4, 12, and 16 |
| Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Summary of change from baseline in pulse rate at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. | Weeks 1, 4, 12, and 16 |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Monika Sulovsky | Vienna | 1010 | Austria |
| Institute Of Cosmetic | Oakville | Ontario | L6J7W5 | Canada |
| Sweat Clinics of Canada | Toronto | Ontario | M5R3N8 | Canada |
| Withdrawal by Subject |
|
| BG001 | Group B: 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). 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skintype | The Fitzpatrick skin type is a scale that classifies skin based on its reaction to sun exposure, specifically its tendency to burn or tan. It includes six types: Type I: very pale white skin, burns without tanning; Type II: white skin, burns and does not tan easily; Type III: fair skin, burns first then tans; Type IV: light brown skin, burns a little and tans easily; Type V: brown skin, easily tans to a darker color and rarely burns; Type VI: dark brown or black skin, never burns but tans darker | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Group A: 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). 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. |
| OG001 | Group B: 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). 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. |
|
|
| Secondary | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. | The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4. | Posted | Count of Participants | Participants | Weeks 1, 2, 8, 12 and 16 |
|
|
|
| Secondary | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 2 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. | The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4. | Posted | Count of Participants | Participants | Weeks 1, 2, 4, 8, 12 and 16 |
|
|
|
| Secondary | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at rest over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. | The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4. | Posted | Count of Participants | Participants | Weeks 1, 2, 4, 8, 12 and 16 |
|
|
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| Secondary | Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment | Time to onset of effect in days, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Onset of effect is defined as at least 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale - Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. GLS-I and GLS-S both use the same 4-point scale, ranked as 0 (No lines/minimal lines), 1 (Mild lines), 2 (Moderate lines) and 3 (Severe lines). | The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4. | Posted | Median | Inter-Quartile Range | Days | From treatment at Day 0 to Week 4 |
|
|
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| Secondary | Duration of Effect Based on Independent Investigator Assessment and Subject Assessment | For subjects who are responders at week 4, duration of effect in days is assessed based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Effect is deemed to be lost when scores return to Baseline or worse values. Duration of effect is defined as (the date that loss of response occurred) - (date of single study treatment ) + 1. | The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4. | Posted | Median | 95% Confidence Interval | Days | 16 Weeks |
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|
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| Secondary | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Summary of FACE-Q satisfaction with outcome scale based on subject assessment at weeks 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." | The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4. | Posted | Count of Participants | Participants | Weeks 4, 12 and 16 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Frequency, seriousness and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest (AESIs), as well as causal relationship to the study medication and the study procedure, during the entire study period. A subject with multiple occurrences of an adverse event is counted only once within the worst severity category. | The population consists of all subjects who received at least one injection with the study medication. | Posted | Count of Participants | Participants | through study completion, an average of 16 weeks |
|
|
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| Secondary | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Summary of change from baseline in diastolic/systolic blood pressure at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. | The population consists of all subjects who received at least one injection with the study medication. Only subjects with available data at the respective visit were analyzed. | Posted | Mean | Standard Deviation | millimeters of mercury | Weeks 1, 4, 12, and 16 |
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| Secondary | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Summary of change from baseline in pulse rate at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. | The population consists of all subjects who received at least one injection with the study medication. Only subjects with available data at the respective visit were analyzed. | Posted | Mean | Standard Deviation | beats/min | Weeks 1, 4, 12, and 16 |
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| 0 |
| 100 |
| 0 |
| 100 |
| 11 |
| 100 |
| EG001 | 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). 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. | 0 | 100 | 1 | 100 | 15 | 100 |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (22.1) | Non-systematic Assessment |
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| Viral test positive | Investigations | MedDRA (22.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (22.1) | Non-systematic Assessment |
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Not provided
Not provided
| Responder Rate at Week 2 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 2 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 8 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 8 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 12 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 12 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 16 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 16 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 2 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 2 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 4 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 4 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 8 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 8 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 12 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 12 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 16 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 16 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 2 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 2 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 4 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 4 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 8 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 8 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 12 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 12 based on Subject's In-clinic Assessment |
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| Responder Rate at Week 16 based on Investigator's In-clinic Assessment |
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| Responder Rate at Week 16 based on Subject's In-clinic Assessment |
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| Duration of effect for responders at Week 4 based on Subject's in-clinic assessment |
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| Somewhat agree |
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| Definitely agree |
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| Missing |
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| Week 4 - expected |
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| Week 4 - great |
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| Week 4 - look in the mirror |
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| Week 4 - fantastic |
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| Week 4 - miraculous |
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| Week 12 - pleased |
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| Week 12 - expected |
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| Week 12 - great |
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| Week 12 - look in the mirror |
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| Week 12 - fantastic |
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| Week 12 - miraculous |
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| Week 16 - pleased |
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| Week 16 - expected |
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| Week 16 - great |
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| Week 16 - look in the mirror |
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| Week 16 - fantastic |
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| Week 16 - miraculous |
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| Subjects with any treatment-emergent adverse events of special interest |
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| Subjects with any severe treatment-emergent adverse events |
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| Subjects with any moderate treatment-emergent adverse events |
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| Subjects with any mild treatment-emergent adverse events |
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| Subjects with any treatment-emergent adverse events related to study medication |
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| Subjects with any treatment-emergent adverse events related to study procedure |
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| Diastolic Blood Pressure (mmHg) - Week 4 - Change from Baseline |
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| Diastolic Blood Pressure (mmHg) - Week 12 - Change from Baseline |
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| Diastolic Blood Pressure (mmHg) - Week 16 - Change from Baseline |
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| Systolic Blood Pressure (mmHg) - Week 1 - Change from Baseline |
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| Systolic Blood Pressure (mmHg) - Week 4 - Change from Baseline |
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| Systolic Blood Pressure (mmHg) - Week 12 - Change from Baseline |
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| Systolic Blood Pressure (mmHg) - Week 16 - Change from Baseline |
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| Pulse Rate (beats/min) - Week 4 - Change from Baseline |
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| Pulse Rate (beats/min) - Week 12 - Change from Baseline |
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| Pulse Rate (beats/min) - Week 16 - Change from Baseline |
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