Trial Outcomes & Findings for IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines (NCT NCT00770211)
NCT ID: NCT00770211
Last Updated: 2011-10-07
Results Overview
Composite endpoint CETS constituted by two efficacy variables: 1. The investigator's assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. 2. Patient's assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor. A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
271 participants
Primary outcome timeframe
Baseline to Day 30
Results posted on
2011-10-07
Participant Flow
Participant milestones
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
89
|
|
Overall Study
COMPLETED
|
181
|
87
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
Baseline characteristics by cohort
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 Participants
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 Participants
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.9 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 30Population: Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to 'no 2-point responder'.
Composite endpoint CETS constituted by two efficacy variables: 1. The investigator's assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. 2. Patient's assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor. A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables.
Outcome measures
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 Participants
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 Participants
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale
|
87 Particpants
|
0 Particpants
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder defined as having a rating of none or mild
The investigator's assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.
Outcome measures
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 Participants
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 Participants
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)
|
157 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.
Patient's assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out). A subject was a responder if a 1-point improvement occurred compared to baseline.
Outcome measures
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 Participants
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 Participants
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale
|
137 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder as having a rating of none or mild
The investigator's assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.
Outcome measures
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 Participants
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 Participants
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
Responders at Maximum Frown at Day 30 by Investigator's Rating on FWS
|
139 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.
Patient's assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor. A subject was a responder if a 1-point improvement occurred compared to baseline.
Outcome measures
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 Participants
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 Participants
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
1-point Responders at Maximum Frown at Day 30 by Patient's Assessment on 4-point Scale
|
152 Participants
|
10 Participants
|
Adverse Events
IncobotulinumtoxinA (Xeomin) (20 Units)
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 participants at risk
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 participants at risk
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/182 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
1.1%
1/89 • Number of events 1 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/182 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
1.1%
1/89 • Number of events 1 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
Other adverse events
| Measure |
IncobotulinumtoxinA (Xeomin) (20 Units)
n=182 participants at risk
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
|
Placebo
n=89 participants at risk
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.3%
17/182 • Number of events 20 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
5.6%
5/89 • Number of events 6 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
9/182 • Number of events 10 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
5.6%
5/89 • Number of events 6 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Nervous system disorders
Sinus headache
|
3.8%
7/182 • Number of events 7 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
1.1%
1/89 • Number of events 1 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Infections and infestations
Sinusitis
|
3.3%
6/182 • Number of events 6 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
4.5%
4/89 • Number of events 4 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
4/182 • Number of events 4 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
0.00%
0/89 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.6%
3/182 • Number of events 3 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
2.2%
2/89 • Number of events 2 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
4/182 • Number of events 4 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
1.1%
1/89 • Number of events 1 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/182 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
2.2%
2/89 • Number of events 2 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/182 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
2.2%
2/89 • Number of events 2 • All SAEs/AEs after injection were reported. All subjects experiencing SAEs/AEs were to be monitored until AE was resolved or stabilized or until a plausible explanation for the cause of the event had been found.
Data pertaining to AEs were collected during each study visit either based on the subject's spontaneous description or by investigator's inquiry or discovered in the course of examinations done during the visit. The table of Adverse Events includes all non-serious AEs.
|
Additional Information
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