A Phase 2 interventional study of Botulinum toxin A "BoNT/A-DP" and Botulinum toxin A "Botox Cosmetics" in Frown Lines, sponsored by Croma-Pharma GmbH. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Croma-Pharma GmbH · Phase 2, Interventional, and Treatment
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.
Croma-Pharma GmbH is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
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).
Biological: Botulinum toxin A "BoNT/A-DP"
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).
Biological: Botulinum toxin A "Botox Cosmetics"
To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
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.
Time frame: week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 1, 4, 12, and 16
| Milestone | Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) | Group B (n=100): Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Started | 100 | 100 |
| Completed | 97 | 95 |
| Not completed | 3 | 5 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 4 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Participants | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Responder based on Investigator's In-clinic Assessment | 95 | 97 |
| Responder based on Subject's In-clinic Assessment | 81 | 88 |
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.
| Participants | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 93 | 90 |
| Responder Rate at Week 1 based on Subject's In-clinic Assessment | 80 | 83 |
| Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 93 | 95 |
| Responder Rate at Week 2 based on Subject's In-clinic Assessment | 83 | 91 |
| Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 84 | 89 |
| Responder Rate at Week 8 based on Subject's In-clinic Assessment | 60 | 76 |
| Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 66 | 78 |
| Responder Rate at Week 12 based on Subject's In-clinic Assessment | 43 | 56 |
| Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 47 | 61 |
| Responder Rate at Week 16 based on Subject's In-clinic Assessment | 35 | 46 |
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.
| Participants | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 80 | 79 |
| Responder Rate at Week 1 based on Subject's In-clinic Assessment | 68 | 72 |
| Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 83 | 86 |
| Responder Rate at Week 2 based on Subject's In-clinic Assessment | 75 | 83 |
| Responder Rate at Week 4 based on Investigator's In-clinic Assessment | 82 | 88 |
| Responder Rate at Week 4 based on Subject's In-clinic Assessment | 67 | 81 |
| Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 64 | 70 |
| Responder Rate at Week 8 based on Subject's In-clinic Assessment | 44 | 65 |
| Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 37 | 52 |
| Responder Rate at Week 12 based on Subject's In-clinic Assessment | 27 | 39 |
| Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 22 | 33 |
| Responder Rate at Week 16 based on Subject's In-clinic Assessment | 18 | 32 |
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.
| Participants | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 57 | 53 |
| Responder Rate at Week 1 based on Subject's In-clinic Assessment | 58 | 58 |
| Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 65 | 64 |
| Responder Rate at Week 2 based on Subject's In-clinic Assessment | 70 | 64 |
| Responder Rate at Week 4 based on Investigator's In-clinic Assessment | 67 | 68 |
| Responder Rate at Week 4 based on Subject's In-clinic Assessment | 68 | 70 |
| Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 63 | 62 |
| Responder Rate at Week 8 based on Subject's In-clinic Assessment | 57 | 60 |
| Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 58 | 53 |
| Responder Rate at Week 12 based on Subject's In-clinic Assessment | 45 | 48 |
| Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 45 | 52 |
| Responder Rate at Week 16 based on Subject's In-clinic Assessment | 36 | 48 |
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).
| Days | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment | 8.0 (7.0 to 9.0) | 8.0 (7.5 to 8.0) |
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.
| Days | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Duration of effect for responders at Week 4 based on Investigator's in-clinic assessment | 132 (117 to 132) | NA (119 to NA) |
| Duration of effect for responders at Week 4 based on Subject's in-clinic assessment | 116 (114 to 121) | NA (117 to NA) |
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."
| Participants | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Week 4 - pleased — Definitely disagree | 2 | 0 |
| Week 4 - pleased — Somewhat disagree | 3 | 3 |
| Week 4 - pleased — Somewhat agree | 17 | 12 |
| Week 4 - pleased — Definitely agree | 77 | 84 |
| Week 4 - pleased — Missing | 0 | 1 |
| Week 4 - expected — Definitely disagree | 4 | 0 |
| Week 4 - expected — Somewhat disagree | 5 | 6 |
| Week 4 - expected — Somewhat agree | 33 | 34 |
| Week 4 - expected — Definitely agree | 57 | 59 |
| Week 4 - expected — Missing | 0 | 1 |
| Week 4 - great — Definitely disagree | 2 | 1 |
| Week 4 - great — Somewhat disagree | 8 | 7 |
| Week 4 - great — Somewhat agree | 23 | 15 |
| Week 4 - great — Definitely agree | 66 | 76 |
| Week 4 - great — Missing | 0 | 1 |
| Week 4 - look in the mirror — Definitely disagree | 1 | 1 |
| Week 4 - look in the mirror — Somewhat disagree | 12 | 8 |
| Week 4 - look in the mirror — Somewhat agree | 31 | 30 |
| Week 4 - look in the mirror — Definitely agree | 55 | 60 |
| Week 4 - look in the mirror — Missing | 0 | 1 |
| Week 4 - fantastic — Definitely disagree | 4 | 3 |
| Week 4 - fantastic — Somewhat disagree | 13 | 11 |
| Week 4 - fantastic — Somewhat agree | 25 | 18 |
| Week 4 - fantastic — Definitely agree | 57 | 67 |
| Week 4 - fantastic — Missing | 0 | 1 |
| Week 4 - miraculous — Definitely disagree | 11 | 4 |
| Week 4 - miraculous — Somewhat disagree | 16 | 19 |
| Week 4 - miraculous — Somewhat agree | 32 | 27 |
| Week 4 - miraculous — Definitely agree | 40 | 49 |
| Week 4 - miraculous — Missing | 0 | 1 |
| Week 12 - pleased — Definitely disagree | 10 | 3 |
| Week 12 - pleased — Somewhat disagree | 6 | 7 |
| Week 12 - pleased — Somewhat agree | 28 | 24 |
| Week 12 - pleased — Definitely agree | 50 | 60 |
| Week 12 - pleased — Missing | 5 | 6 |
| Week 12 - expected — Definitely disagree | 11 | 6 |
| Week 12 - expected — Somewhat disagree | 11 | 9 |
| Week 12 - expected — Somewhat agree | 29 | 33 |
| Week 12 - expected — Definitely agree | 43 | 46 |
| Week 12 - expected — Missing | 5 | 6 |
| Week 12 - great — Definitely disagree | 9 | 5 |
| Week 12 - great — Somewhat disagree | 14 | 12 |
| Week 12 - great — Somewhat agree | 28 | 22 |
| Week 12 - great — Definitely agree | 43 | 55 |
| Week 12 - great — Missing | 5 | 6 |
| Week 12 - look in the mirror — Definitely disagree | 13 | 4 |
| Week 12 - look in the mirror — Somewhat disagree | 14 | 15 |
| Week 12 - look in the mirror — Somewhat agree | 33 | 36 |
| Week 12 - look in the mirror — Definitely agree | 34 | 39 |
| Week 12 - look in the mirror — Missing | 5 | 6 |
| Week 12 - fantastic — Definitely disagree | 12 | 7 |
| Week 12 - fantastic — Somewhat disagree | 22 | 18 |
| Week 12 - fantastic — Somewhat agree | 27 | 27 |
| Week 12 - fantastic — Definitely agree | 33 | 42 |
| Week 12 - fantastic — Missing | 5 | 6 |
| Week 12 - miraculous — Definitely disagree | 25 | 8 |
| Week 12 - miraculous — Somewhat disagree | 14 | 27 |
| Week 12 - miraculous — Somewhat agree | 31 | 30 |
| Week 12 - miraculous — Definitely agree | 24 | 29 |
| Week 12 - miraculous — Missing | 5 | 6 |
| Week 16 - pleased — Definitely disagree | 12 | 5 |
| Week 16 - pleased — Somewhat disagree | 10 | 8 |
| Week 16 - pleased — Somewhat agree | 21 | 20 |
| Week 16 - pleased — Definitely agree | 54 | 62 |
| Week 16 - pleased — Missing | 2 | 5 |
| Week 16 - expected — Definitely disagree | 12 | 6 |
| Week 16 - expected — Somewhat disagree | 14 | 12 |
| Week 16 - expected — Somewhat agree | 31 | 31 |
| Week 16 - expected — Definitely agree | 40 | 46 |
| Week 16 - expected — Missing | 2 | 5 |
| Week 16 - great — Definitely disagree | 10 | 8 |
| Week 16 - great — Somewhat disagree | 20 | 13 |
| Week 16 - great — Somewhat agree | 20 | 18 |
| Week 16 - great — Definitely agree | 47 | 56 |
| Week 16 - great — Missing | 2 | 5 |
| Week 16 - look in the mirror — Definitely disagree | 12 | 11 |
| Week 16 - look in the mirror — Somewhat disagree | 20 | 15 |
| Week 16 - look in the mirror — Somewhat agree | 29 | 30 |
| Week 16 - look in the mirror — Definitely agree | 36 | 39 |
| Week 16 - look in the mirror — Missing | 2 | 5 |
| Week 16 - fantastic — Definitely disagree | 17 | 10 |
| Week 16 - fantastic — Somewhat disagree | 19 | 17 |
| Week 16 - fantastic — Somewhat agree | 24 | 21 |
| Week 16 - fantastic — Definitely agree | 37 | 47 |
| Week 16 - fantastic — Missing | 2 | 5 |
| Week 16 - miraculous — Definitely disagree | 26 | 14 |
| Week 16 - miraculous — Somewhat disagree | 14 | 20 |
| Week 16 - miraculous — Somewhat agree | 35 | 33 |
| Week 16 - miraculous — Definitely agree | 22 | 28 |
| Week 16 - miraculous — Missing | 2 | 5 |
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.
| Participants | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Subjects with any treatment-emergent adverse events | 25 | 22 |
| Subjects with any serious treatment-emergent adverse events | 0 | 1 |
| Subjects with any treatment-emergent adverse events of special interest | 0 | 1 |
| Subjects with any severe treatment-emergent adverse events | 0 | 0 |
| Subjects with any moderate treatment-emergent adverse events | 5 | 4 |
| Subjects with any mild treatment-emergent adverse events | 20 | 18 |
| Subjects with any treatment-emergent adverse events related to study medication | 4 | 3 |
| Subjects with any treatment-emergent adverse events related to study procedure | 6 | 8 |
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.
| millimeters of mercury | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Diastolic Blood Pressure (mmHg) - Week 1 - Change from Baseline | 0.9 ± 8.48 | -1.9 ± 8.50 |
| Diastolic Blood Pressure (mmHg) - Week 4 - Change from Baseline | 0.1 ± 8.29 | -1.9 ± 8.80 |
| Diastolic Blood Pressure (mmHg) - Week 12 - Change from Baseline | -0.1 ± 9.64 | -1.2 ± 10.19 |
| Diastolic Blood Pressure (mmHg) - Week 16 - Change from Baseline | 1.0 ± 9.30 | -1.6 ± 10.85 |
| Systolic Blood Pressure (mmHg) - Week 1 - Change from Baseline | 0.2 ± 10.84 | -2.4 ± 12.29 |
| Systolic Blood Pressure (mmHg) - Week 4 - Change from Baseline | 0.3 ± 11.44 | -0.9 ± 12.78 |
| Systolic Blood Pressure (mmHg) - Week 12 - Change from Baseline | 0.6 ± 11.79 | -1.3 ± 14.77 |
| Systolic Blood Pressure (mmHg) - Week 16 - Change from Baseline | 1.5 ± 12.30 | -1.5 ± 15.52 |
Summary of change from baseline in pulse rate at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic.
| beats/min | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Pulse Rate (beats/min) - Week 1 - Change from Baseline | 2.2 ± 10.25 | -0.4 ± 9.94 |
| Pulse Rate (beats/min) - Week 4 - Change from Baseline | 1.0 ± 11.60 | 1.6 ± 9.46 |
| Pulse Rate (beats/min) - Week 12 - Change from Baseline | 1.2 ± 11.72 | -0.2 ± 11.90 |
| Pulse Rate (beats/min) - Week 16 - Change from Baseline | 1.9 ± 11.02 | 0.5 ± 11.31 |
Collected over 16 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) | 0/100 (0%) | 0/100 (0%) | 11/100 (11%) |
| Group B (n=100): Botox Cosmetic (20 U, 0.5 mL) | 0/100 (0%) | 1/100 (1%) | 15/100 (15%) |
| Event | Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) | Group B (n=100): Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| Lower Limb FractureInjury, poisoning and procedural complications | 0/100 | 1/100 |
| Event | Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) | Group B (n=100): Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|
| HeadacheNervous system disorders | 6/100 | 10/100 |
| Viral test positiveInvestigations | 0/100 | 3/100 |
| Corona virus infectionInfections and infestations | 2/100 | 1/100 |
| Muscle strainInjury, poisoning and procedural complications | 2/100 | 0/100 |
| HypertensionVascular disorders | 1/100 | 2/100 |
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.
| Age, Categorical(Participants) | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 90 | 92 | 182 |
| >=65 years | 9 | 8 | 17 |
| Age, Continuous(years) | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) | Total |
|---|---|---|---|
| Mean | 48.9 ± 11.36 | 48.1 ± 12.04 | 48.5 ± 11.69 |
| Sex: Female, Male(Participants) | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) | Total |
|---|---|---|---|
| Female | 86 | 86 | 172 |
| Male | 13 | 14 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) | Total |
|---|---|---|---|
| Hispanic or Latino | 18 | 21 | 39 |
| Not Hispanic or Latino | 81 | 79 | 160 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 87 | 90 | 177 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 4 | 5 | 9 |
| Region of Enrollment(participants) | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) | Total |
|---|---|---|---|
| Canada | 39 | 34 | 73 |
| Austria | 22 | 23 | 45 |
| United States | 38 | 43 | 81 |
| Fitzpatrick Skintype(Participants) | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) | Total |
|---|---|---|---|
| Type I | 2 | 5 | 7 |
| Type II | 33 | 32 | 65 |
| Type III | 31 | 32 | 63 |
| Type IV | 27 | 27 | 54 |
| Type V | 3 | 2 | 5 |
| Type VI | 3 | 2 | 5 |
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