Trial Outcomes & Findings for NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines (NCT NCT00777803)

NCT ID: NCT00777803

Last Updated: 2012-03-08

Results Overview

The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 381 participants
• Primary outcome timeframe: 4 weeks after injection
• Results posted on: 2012-03-08

Participant Flow

Subjects were randomized according to a ratio of 3:1 to be either treated with IncobotulinumtoxinA (Bocouture®) or with OnabotulinumtoxinA (Vistabel®).

Participant milestones

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®)	OnabotulinumtoxinA (Vistabel®)
Overall Study STARTED	284	97
Overall Study COMPLETED	269	90
Overall Study NOT COMPLETED	15	7

Reasons for withdrawal

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®)	OnabotulinumtoxinA (Vistabel®)
Overall Study Lost to Follow-up	12	5
Overall Study Adverse Event	1	0
Overall Study Non-compliance	2	2

Baseline Characteristics

NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

Baseline characteristics by cohort

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=284 Participants	OnabotulinumtoxinA (Vistabel®) n=97 Participants	Total n=381 Participants Total of all reporting groups
Age Continuous	41.6 years STANDARD_DEVIATION 5.7 • n=5 Participants	42.0 years STANDARD_DEVIATION 6.0 • n=7 Participants	41.7 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	284 Participants n=5 Participants	97 Participants n=7 Participants	381 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=277 Participants	OnabotulinumtoxinA (Vistabel®) n=93 Participants
Responder by Independent Rater's Assessment at Maximum Frown at Week 4	267 participants	89 participants

SECONDARY outcome

Timeframe: 12 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=268 Participants	OnabotulinumtoxinA (Vistabel®) n=88 Participants
Responder by Independent Rater's Assessment at Maximum Frown at Week 12	222 participants	73 participants

SECONDARY outcome

Timeframe: 4 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=277 Participants	OnabotulinumtoxinA (Vistabel®) n=92 Participants
Responder by Independent Rater's Assessment at Rest at Week 4	115 participants	37 participants

SECONDARY outcome

Timeframe: 12 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=268 Participants	OnabotulinumtoxinA (Vistabel®) n=88 Participants
Responder by Independent Rater's Assessment at Rest at Week 12	100 participants	33 participants

SECONDARY outcome

Timeframe: 4 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=277 Participants	OnabotulinumtoxinA (Vistabel®) n=93 Participants
Responder by Investigator's Assessment at Maximum Frown at Week 4	274 participants	89 participants

SECONDARY outcome

Timeframe: 12 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=268 Participants	OnabotulinumtoxinA (Vistabel®) n=88 Participants
Responder by Investigator's Assessment at Maximum Frown at Week 12	220 participants	76 participants

SECONDARY outcome

Timeframe: 4 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=277 Participants	OnabotulinumtoxinA (Vistabel®) n=93 Participants
Responder by Investigator's Assessment at Rest at Week 4	210 participants	66 participants

SECONDARY outcome

Timeframe: 12 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=268 Participants	OnabotulinumtoxinA (Vistabel®) n=88 Participants
Responder by Investigator's Assessment at Rest at Week 12	166 participants	51 participants

SECONDARY outcome

Timeframe: 4 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=277 Participants	OnabotulinumtoxinA (Vistabel®) n=93 Participants
Responder by Patient's Assessment at Maximum Frown at Week 4	260 participants	87 participants

SECONDARY outcome

Timeframe: 12 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=268 Participants	OnabotulinumtoxinA (Vistabel®) n=88 Participants
Responder by Patient's Assessment at Maximum Frown at Week 12	202 participants	71 participants

SECONDARY outcome

Timeframe: 4 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=277 Participants	OnabotulinumtoxinA (Vistabel®) n=93 Participants
Responder by Patient's Assessment at Rest at Week 4	193 participants	70 participants

SECONDARY outcome

Timeframe: 12 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=268 Participants	OnabotulinumtoxinA (Vistabel®) n=88 Participants
Response by Patient's Assessment at Rest at Week 12	152 participants	53 participants

SECONDARY outcome

Timeframe: 4 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=277 Participants	OnabotulinumtoxinA (Vistabel®) n=93 Participants
Responder by Patient's Global Assessment at Week 4	259 participants	86 participants

SECONDARY outcome

Timeframe: 12 weeks after injection

Population: Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.

The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.

Outcome measures

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=268 Participants	OnabotulinumtoxinA (Vistabel®) n=88 Participants
Responder by Patient's Global Assessment at Week 12	229 participants	75 participants

Adverse Events

IncobotulinumtoxinA (Xeomin®/Bocouture®)

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

OnabotulinumtoxinA (Vistabel®)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=284 participants at risk	OnabotulinumtoxinA (Vistabel®) n=97 participants at risk
Injury, poisoning and procedural complications Joint injury	0.35% 1/284 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/97 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.
Infections and infestations Encephalitis viral	0.00% 0/284 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.	1.0% 1/97 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.
Injury, poisoning and procedural complications Tibia fracture	0.35% 1/284 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.	0.00% 0/97 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.

Other adverse events

Measure	IncobotulinumtoxinA (Xeomin®/Bocouture®) n=284 participants at risk	OnabotulinumtoxinA (Vistabel®) n=97 participants at risk
Nervous system disorders Headache	4.2% 12/284 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.	7.2% 7/97 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.
Infections and infestations Nasopharyngitis	3.9% 11/284 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.	4.1% 4/97 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.
Infections and infestations Gastrointestinal infection	0.35% 1/284 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.	2.1% 2/97 • All SAEs/AEs up to 12 weeks after injection. The table of "Other Adverse Events" includes all non-serious AEs. The investigator asked the patient for AEs systematically at each visit.

Additional Information

Matthias Zerm

Merz Pharmaceuticals GmbH

Phone: +49 69 1503

Email: matthias.zerm@merz.de

Results disclosure agreements

• Principal investigator is a sponsor employee No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 wks before submission. Sponsor to give written opinion within 30 d. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
• Publication restrictions are in place

Restriction type: OTHER