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Supplemental Data Table 1. Search query details and summary of results

Database

Query

Results of selection

Comparator

Articles found

Duplicates

Articles excluded

Articles selected

Onabotulinum-toxinA

Abobotulinum-toxinA

Placebo

PubMed

((incobotulinumtoxinA OR “incobotulinumtoxin A” OR “incobotulinum toxin A” OR “botulinum neurotoxin type A” OR botulinum toxin type A OR “free from complexing proteins” OR bocouture OR xeomin OR xeomeen OR “NT 201” OR NT201) AND (onabotulinumtoxinA OR botox OR vistabel OR abobotulinumtoxinA OR azzalure OR dysport OR placebo) AND (glabellar frown lines OR upper facial lines OR forehead lines OR periorbital lines OR crow’s feet OR platysmal bands OR masseteric hypertrophy OR calf slimming OR shoulder slimming OR hyperhidrosis OR upper face wrinkles) AND ("2000/01/01"[Date - Publication] : "2016/01/13"[Date - Publication]) AND (English[Language])) NOT (("case reports"[Publication Type] OR "comment"[Publication Type] OR "congresses"[Publication Type] OR "consensus development conference"[Publication Type] OR "editorial"[Publication Type] OR "letter"[Publication Type] OR "news"[Publication Type] OR "newspaper article"[Publication Type] OR "observational study"[Publication Type] OR "practice guideline"[Publication Type] OR "review"[Publication Type]) OR ("recommendation" OR "guideline" OR "pilot project" OR "pilot study" OR "animal model" OR "cadaver" OR "single-arm"))

307

-

292

15

10a

3a

3

Embase

('incobotulinumtoxina'/exp or incobotulinumtoxina or 'incobotulinumtoxin a'/exp or 'incobotulinumtoxin a' or 'incobotulinum toxin a'/exp or 'incobotulinum toxin a' or 'botulinum neurotoxin type a'/exp or 'botulinum neurotoxin type a' or 'botulinum toxin type a' or 'free from complexing proteins' or 'bocouture'/exp or 'bocouture' or 'xeomin'/exp or 'xeomin' or 'xeomeen' or 'nt 201'/exp or 'nt 201' or 'nt201'/exp or nt201 and ([controlled clinical trial]/lim or [randomized controlled trial]/lim) and ([article]/lim or [article in press]/lim or [conference abstract]/lim or [conference paper]/lim) and [english]/lim and [embase]/lim and [2000-2016]/py) and (onabotulinumtoxina or botox or vistabel or abobotulinumtoxina or azzalure or dysport or placebo) and ('glabellar frown lines' or 'upper facial lines' or 'forehead lines' or 'periorbital lines' or 'platysmal bands' or 'masseteric hypertrophy' or 'crow* feet')

36

35

1

0

0

0

0

a One article compared incobotulinumtoxinA with both onabotulinumtoxinA and abobotulinumtoxinA

Supplemental Data Table 2. Summary of data extracted from the selected articles

Authors

Year

Indication(s)

Study design

N

Treatments

Statistical method

Study size estimate reported/ sufficient power?

Primary efficacy endpoint(s)

Main efficacy findings

Sattler and colleagues1

2010

Glabellar frown lines

Phase III randomized, rater- and patient-blinded, multicenter

381

Inco: 24 U

Ona: 24 U



Non-inferiority based on a difference in response rates (inco – ona) ≤−15%

Yes

Response rate at maximum frown at week 4, where a responder = improvement ≥ 1 point on Facial Wrinkle Scale

Non-inferiority of inco vs. ona at week 4; also at week 12

Kane and colleagues2

2015

Glabellar frown lines

Randomized, double-blinded, parallel-group, multicenter

250

Inco: 20 U

Ona: 20 U



Equivalence based on a confidence interval for the difference in response rates within ±15%

Yes

Clinical response to treatment at 1 month, defined as improvement ≥ 1 point from baseline, measured by Facial Wrinkle Scale

Equivalent response rates for inco and ona at 1 month

Prager and Rappl3

2012

Glabellar frown lines

Phase IV, randomized, split-face, multicenter

35

Inco: 20 U

Ona: 30 U



Non-superiority in rates of response but no statistical test

Not reported

Proportion of subjects with an improvement ≥1 point on Merz Aesthetics Scale at week 4, month 4, and month 6

Non-superiority of ona vs. inco at 4 weeks, 4 and 6 months































Moers-Carpi and colleagues4

2012

Glabellar frown lines

Double-blind, randomized, parallel-group, multicenter

224

Inco: 30 U

Ona: 20 U



Equivalence based on a confidence interval for the difference in response rates within ±15%

Yes

Response - increase of ≥1 point in severity of glabellar frown lines at maximum contraction as measured by Facial Wrinkle Scale at day 28

Equivalent response rate at day 28, but rates higher at days 84, 98, 112 for ona

Rappl and colleagues5

2013

Glabellar frown lines

Randomized, double-blind, single-center

180

Inco: 21 U

Ona: 21 U

Abo: 63 U


Kaplan-Meier curves

Not reported

Merz Aesthetics Scale on days 2, 3, 4, 5, 6, 7, 8, 90, 120, 150, and 180; onset of treatment = improvement ≥ 1 point on Merz Aesthetics Scale; duration until improvement returns to baseline

Onset of treatment faster and duration slightly longer with inco

Yeilding and Fezza6

2015

Glabellar frown lines + periorbital lines + forehead lines

Split-face, randomized, double-blind, single-center

45

Inco: 22.5 U

Ona: 22.5 U



T-tests and “modified” t-tests

Not reported

Flynn assessment scales at day 3, week 2, month 3, and month 4

Significantly greater improvement of dynamic but not static scores for ona vs. inco at 3 days, 2 weeks, and 3 months for forehead lines but not for glabellar frown lines or periorbital lines

Hexsel and colleagues7

2015

Forehead lines

Randomized, double-blind, two-center

80

Inco: 12 U

Abo: 30 U



Chi-square test

Not reported

Wrinkle Severity Scale at days 28, 84, 112, and 140

No significant differences at days 28, 84, 112, or 140

Prager and colleagues8

2010

Periorbital lines

Split-face, randomized, double-blind, single center, proof-of-concept

21

Inco: 12 U

Ona: 12 U



McNemar chi-square test

Not reported

Periorbital lines at maximum contraction by Facial Wrinkle Scale; responder = improvement ≥1 point

Response rates not significantly different at 1, 2, 3 or 4 months

Lee and colleagues9

2014

Periorbital lines and masseteric hypertrophy

Split-face, randomized, double-blind

56

Periorbital lines

Inco: 7.5 U

Ona: 7.5 U

Masseteric hypertrophy

Inco: 25 U

Ona: 25 U


Paired t test or Wilcoxon signed-rank test

Not reported

Periorbital lines scored by Fitzpatrick Wrinkle Classification System at 1 and 16 weeks; hypertrophy scored using a 10-point visual analogue scale at 4 and 16 weeks

No significant differences in periorbital lines at 1 or 16 weeks or masseteric hypertrophy at 4 or 16 weeks

Muti and Harrington10

2015

Periorbital lines

Randomized, rater- and patient-blinded, split-face with cross-over evaluation, single center

14

Inco: 12 U

Ona: 12 U



Student’s t-test

Not reported

Severity of periorbital lines at 1 and 3 months by Merz Aesthetics scale

No significant difference in periorbital lines at 1 or 3 months

Saybel and colleagues11

2015

Periorbital lines

Randomized, rater- and patient-blinded, split-face

20

Inco: 9 U

Abo: 27 U



Mann-Whitney U-test or Student’s t-test

Not reported

Periorbital lines assessed by Merz Aesthetics Scale; responder = improvement ≥ 1 point

No significant difference in improvement in periorbital lines at 2 weeks, 4 months, or 6 months

Campanati and colleagues12

2014

Palmar hyperhidrosis

Double-blind, split-hand, single-center, pilot

25

Inco: 100-150 U

Ona: 100-150 U



Mann-Whitney U test or Wilcoxon test

Not reported

Sweating measured by Minor’s test, scored on a 5-point scale by investigators

No significant difference in sweating at 4, 12, or 24 weeks

Carruthers and colleagues13

2013

Glabellar frown lines

Phase III randomized, double-blind placebo-controlled, multicenter

276

Inco: 20 U

Fisher exact test

Not reported

Composite treatment success at day 30 (improvement ≥2 point on Facial Wrinkle Scale assessed by investigator; and improvement at maximum frown on a 4-pt scale assessed by patient)

Response rate at day 30 significantly higher for inco than placebo

Hanke and colleagues14

2013

Glabellar frown lines

Phase III randomized, double-blind placebo-controlled, multicenter

271

Inco: 20 U

Cochran-Mantel-Haenszel test

Not reported

Composite treatment success at day 30 (improvement ≥2 point on Facial Wrinkle Scale assessed by investigator; and improvement at maximum frown on a 4-pt scale assessed by patient)

Inco significantly better than placebo at reducing GFLs

Kerscher and colleagues15

2015

Glabellar frown lines + periorbital lines + forehead lines

Phase III, randomized, double-blind, placebo-controlled, multicenter

156

Inco: 20 U for GFLs, 10-20 U for forehead lines, 24 U for periorbital lines

Logistic regression

Not reported

Merz Aesthetics Scale at maximum contraction on day 30 for each area

Inco significantly better than placebo at reducing glabellar frown lines, periorbital lines, forehead lines, and combination of upper facial lines

Abo=abobotulinumtoxinA; inco=incobotulinumtoxinA; Ona=onabotulinumtoxinA; GFLs = glabellar frown lines

References

1. Sattler G, Callander MJ, Grablowitz D, Walker T, et al. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg 2010;36 Suppl 4:2146-54.

2. Kane MA, Gold MH, Coleman WP, 3rd, Jones DH, et al. A randomized, double-blind trial to investigate the equivalence of incobotulinumtoxinA and onabotulinumtoxinA for glabellar frown lines. Dermatol Surg 2015;41:1310-9.

3. Prager W, Rappl T. Phase IV study comparing incobotulinumtoxinA and onabotulinumtoxinA using a 1:1.5 dose-conversion ratio for the treatment of glabellar frown lines. J Cosmet Dermatol 2012;11:267-71.

4. Moers-Carpi M, Dirschka T, Feller-Heppt G, Hilton S, et al. A randomised, double-blind comparison of 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA for glabellar lines. J Cosmet Laser Ther 2012;14:296-303.

5. Rappl T, Parvizi D, Friedl H, Wiedner M, et al. Onset and duration of effect of incobotulinumtoxinA, onabotulinumtoxinA, and abobotulinumtoxinA in the treatment of glabellar frown lines: a randomized, double-blind study. Clin Cosmet Investig Dermatol 2013;6:211-9.

6. Yeilding RH, Fezza JP. A Prospective, split-face, randomized, double-blind study comparing onabotulinumtoxinA to incobotulinumtoxinA for upper face wrinkles. Plast Reconstr Surg 2015;135:1328-35.

7. Hexsel D, Soirefmann M, Porto MD, Siega C, et al. Fields of muscular and anhidrotic effects of 2 botulinum toxin-A commercial preparations: a prospective, double-blind, randomized, multicenter study. Dermatol Surg 2015;41 Suppl 1:S110-8.

8. Prager W, Wissmuller E, Kollhorst B, Williams S, et al. Comparison of two botulinum toxin type A preparations for treating crow's feet: a split-face, double-blind, proof-of-concept study. Dermatol Surg 2010;36 Suppl 4:2155-60.

9. Lee JH, Park JH, Lee SK, Han KH, et al. Efficacy and safety of incobotulinum toxin A in periocular rhytides and masseteric hypertrophy: side-by-side comparison with onabotulinum toxin A. J Dermatolog Treat 2014;25:326-30.

10. Muti G, Harrington L. A prospective rater- and subject-blinded study comparing the efficacy of incobotulinumtoxinA and onabotulinumtoxinA to treat crow's feet: a clinical crossover evaluation. Dermatol Surg 2015;41 Suppl 1:S39-46.

11. Saybel A, Artemenko A, Nikitin S, Kurenkov A. A prospective, neurophysiologic comparative study to assess the efficacy and duration of effect of incobotulinumtoxinA and abobotulinumtoxinA in the treatment of crow's feet. J Drugs Dermatol 2015;14:1291-6.

12. Campanati A, Giuliodori K, Martina E, Giuliano A, et al. Onabotulinumtoxin type A (Botox®) versus Incobotulinumtoxin type A (Xeomin®) in the treatment of focal idiopathic palmar hyperhidrosis: results of a comparative double-blind clinical trial. J Neural Transm (Vienna) 2014;121:21-6.

13. Carruthers A, Carruthers J, Coleman WP, 3rd, Donofrio L, et al. Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines. Dermatol Surg 2013;39:551-8.



14. Hanke CW, Narins RS, Brandt F, Cohen JL, et al. A randomized, placebo-controlled, double-blind phase III trial investigating the efficacy and safety of incobotulinumtoxinA in the treatment of glabellar frown lines using a stringent composite endpoint. Dermatol Surg 2013;39:891-9.

15. Kerscher M, Rzany B, Prager W, Turnbull C, et al. Efficacy and safety of incobotulinumtoxinA in the treatment of upper facial lines: results from a randomized, double-blind, placebo-controlled, phase III study. Dermatol Surg 2015;41:1149-57.


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