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. 2020 Dec 1;13(12):E56–E83.

TABLE 3.

Duration of response—single-cycle, comparator studies

STUDY De Boulle 200853 De Morais 201240 Elridy 201728 Hexsel 201241
INDICATION Glabellar lines and lateral canthal lines (N=40) Hyperdynamic forehead lines (N=12) Lateral canthal lines (N=40) Forehead wrinkles (N=58)
STUDY DESIGN Non-randomized, open-label, cross-over study Intra-individual controlled study, randomized, double-blind, split-face pilot study Randomized, single-blind, split-face study versus onaBoNT-A Prospective, single-center, double-blind, randomized clinical trial versus onaBoNT-A
TREATMENT Previous treatment with onaBoNT-A was replicated using aboBoNT-A using a 1:2.5 dose conversion ratio AboBoNT-A, 51 Speywood units
OnaBoNT-A, incoBoNT-A and CBTX-A, 17 mouse Units		 AboBoNT-A 15U (n=20)
OnaBoNT-A 6U (n=20)		 Group A:
  • •

    AboBoNT-A 4U on one side of the forehead

  • •

    OnaBoNT-A 2U on the contralateral side

Group B:
  • •

    AboBoNT-A 5U on one side of the forehead

  • •

    OnaBoNT-A 2U on the contralateral side
MUSCLE TARGET Glabellar area, alone or in conjunction with the lateral canthal lines and/or forehead area Frontalis muscle, including lower portions where fibers overlap with glabella complex Three injection points across the canthal region (orbicularis oculi) Frontalis muscle
MEASURE OF DURATION Patient-reported efficacy for making them look younger, more rested or less stressed (4-point scale, from ineffective to very effective) Proportion of patients scored mild or absent on a 4-point forehead wrinkle scale (4-point scale: absent, mild, moderate, severe) from digital photographs Duration of improvement was defined as the duration taken until the regression of improvement to baseline. Assessed on a scale from 0–4:
  • •

    0: No improvement

  • •

    1: Regression by the first follow-up session (Day 7)

  • •

    2: Regression by the second follow-up session (Day 30)

  • •

    3: Regression by the third follow-up session (Day 120)

  • •

    4: No regression until the third follow-up session (Day 120)

Assessment was made on digital photographs in both static and dynamic postures		 Wrinkle severity scores (4-point scale) were assessed
ASSESSMENT TIME POINTS AFTER 12 WEEKS Weeks 12 and 16 (aboBoNT-A) versus Week 20 (onaBoNT-A) Day 150 Day 120 Day 112
RESULTS RELEVANT TO DURATION Proportion of patients reporting “effective” or “very effective” in making them look younger:
  • •

    AboBoNT-A Week 12 and 16: 59% and 36%, respectively

  • •

    OnaBoNT-A Week 20: 83% (p≤0.001 versus aboBoNT-A Week 16)

Proportion of patients reporting “effective” or “very effective” in making them look rested:
  • •

    AboBoNT-A Week 12 and 16: 65% and 39%, respectively

  • •

    OnaBoNT-A Week 20: 90% (p≤0.001 versus aboBoNT-A Week 16)

Proportion of patients reporting “effective” or “very effective” in making them look less stressed:
  • •

    AboBoNT-A Week 12 and 16: 56%, and 33%, respectively

  • •

    OnaBoNT-A Week 20: 83% (p≤0.001 versus aboBoNT-A Week 16)

 Mean forehead wrinkle scales at maximum frown of the frontalis muscle at Day 150:
  • •

    AboBoNT-A: 1.85

  • •

    OnaBoNT-A: 2.0

  • •

    IncoBoNT-A: 2.3

  • •

    CBTX-A: 1.85

A reduction from baseline of ≥1 point was shown in 30% of patients at Day 150.
There was no statistically significant difference between treatment in the maintenance of improvement (p=0.528).		 Percentage of patients with regression to baseline at Day 120 (static posture):
  • •

    AboBoNT-A: 20%

  • •

    OnaBoNT-A: 20%

  • •

    p=1.000

Percentage of patients with regression to baseline at Day 120 (dynamic posture):
  • •

    AboBoNT-A: 20%

  • •

    OnaBoNT-A: 40%

  • •

    p=0.046

 Investigator-assessed wrinkle severity score by number of patients assessed as none/mild/moderate/severe at Day 112:
Group A at rest:
  • •

    AboBoNT-A: 8, 17, 1, and n/a, respectively

  • •

    OnaBoNT-A: 9, 16, 1, and n/a, respectively

Group B at rest:
  • •

    AboBoNT-A: 8, 19, 1, and n/a, respectively

  • •

    OnaBoNT-A: 7, 20, 1, and n/a, respectively

Group A at maximum contraction:
  • •

    AboBoNT-A: 2, 7, 13, and 4, respectively

  • •

    OnaBoNT-A: 2, 7, 13, and 4, respectively

Group B at maximum contraction:
  • •

    AboBoNT-A: 2, 15, 8, and 3, respectively

  • •

    OnaBoNT-A: n/a, 12, 13, and 3 respectively

Significant difference in Group B at maximum contraction (p<0.008) in favor of aboBoNT-A.
SPONSOR Allergan Not Specified None Ipsen (research grant to the Brazilian Center for Studies in Dermatology)
STUDY Hexsel 201542 Karsai 200733 Kassir 201332 Lew 200251
INDICATION Forehead wrinkles (N=80) Forehead wrinkles (N=26) Glabellar rhytids and lateral canthal lines (N=93) Facial wrinkle lines (N=20)
STUDY DESIGN Prospective, double-blind, randomized, multicenter study versus incoBoNT-A Randomized, double-blind, split-face study Prospective, comparative, triple-blinded, single-center, randomized, internally controlled clinical trial Comparative, randomized study of aboBoNT-A and onaBoNT-A
TREATMENT AboBoNT-A 30U on one side of the forehead and incoBoNT-A 12U on the other
Patients were randomized to which side received which product		 AboBoNT-A 36U (right side of forehead)
OnaBoNT-A 12U (left side of forehead)		 Glabellar:
  • •

    AboBoNT-A 20U

  • •

    OnaBoNT-A 8U

Lateral canthal lines:
  • •

    AboBoNT-A 30U

  • •

    OnaBoNT-A 10U

 AboBoNT-A 20U/0.1cm3(n=6)
OnaBoNT-A 5U/0.1cm3(n=14)
MUSCLE TARGET 10 injection points (5 on each side) across the forehead region Frontalis muscle Glabellar: corrugator supercilii muscles
Crow’s feet: lateral canthus muscle		 Lateral canthal area, glabellar area, forehead, nasal dorsum, and nasolabial fold
MEASURE OF DURATION Wrinkle severity scale (none/mild/moderate/severe) at rest and at maximum voluntary contraction of the frontalis muscle Electromyography of frontalis muscle activity at maximum voluntary contraction Evaluator-assessed duration of activity by complete return of muscle activity at the follow-up visit
Response defined as an improvement of ≥1 grade on a 4-point scale, at maximal contraction		 Grade of facial wrinkles evaluated on a scale from 0 to 4
ASSESSMENT TIME POINTS AFTER 12 WEEKS Day 112 and 140 Weeks 13–20 (weekly) Month 3, 4, and 5 Follow up at 6–12 months
RESULTS RELEVANT TO DURATION Number of patients with a severity score of none/mild/moderate/severe at rest (N=80):
AboBoNT-A:
  • •

    Day 112: 17, 40, 17, and 2, respectively

  • •

    Day 140: 8, 35, 27, and 7, respectively

IncoBoNT-A:
  • •

    Day 112: 16, 40, 18, and 2, respectively

  • •

    Day 140: 8, 34, 28, and 7, respectively

Percentage of patients with a severity score of none/mild/moderate/severe at maximal contraction:
AboBoNT-A:
  • •

    Day 112: 1, 32, 28, and 15, respectively

  • •

    Day 140: 1, 14, 36, and 26, respectively

IncoBoNT-A:
  • •

    Day 112: 1, 34, 26, and 15, respectively

  • •

    Day 140: 1, 15, 33, and 28, respectively

No significant difference between products at any time point		 Electromyography of frontalis muscle activity at baseline, Weeks 13, 16, and 20 (estimated from line graph):
  • •

    AboBoNT-A: 32µV, 39µV, and 47µV, respectively

  • •

    OnaBoNT-A: 45µV, 54µV, and 63µV, respectively

p<0.001 for aboBoNT-A versus onaBoNT-A from Week 10 until Week 20, showing a longer lasting effect.
Maximal responses at Week 2 for reference:
  • •

    AboBoNT-A: 27µV

  • •

    OnaBoNT-A: 22µV

 Percentage of responders in the glabellar area at Month 3, 4, and 5:
  • •

    AboBoNT-A: 98%, 83%, and 27%, respectively

  • •

    OnaBoNT-A: 98%, 48%, and 2%, respectively

Response was longer with aboBoNT-A, mean difference 2.5 weeks (p<0.0001)
Percentage of responders in the lateral canthal lines area at Month 3, 4, and 5:
  • •

    AboBoNT-A: 100%, 65%, and 22%, respectively

  • •

    OnaBoNT-A: 98%, 47%, and 0%, respectively

Response was longer with aboBoNT-A, mean difference 1.6 weeks (p<0.0001)		 Mean corrective effect:
  • •

    AboBoNT-A: 64.3%

  • •

    OnaBoNT-A: 72.7%

Most common duration of effective response was five months.
n=5 patients had a duration of >6 months (product not specified)
SPONSOR Not specified None Study center Not specified
STUDY Lowe 201034 Lowe 200543 Lowe 200644
INDICATION Glabellar lines and lateral canthal lines (N=60, Study 1; N=5, Study 3) Glabellar lines (N=30) Glabellar lines (N=62)
STUDY DESIGN Three-part study:
  • •

    Studies 1 and 2 were double-blind randomized studies

  • •

    Study 3 was a treatment comparison, non-placebo study

Results from Study 2 were not relevant to duration.		 Parallel-group, double-blind, randomized, pilot study versus onaBoNT-A Double-blind, randomized, parallel-group study of onaBoNT-A versus aboBoNT-A
TREATMENT Study 1:
  • •

    AboBoNT-A 75U (n=30)

  • •

    OnaBoNT-A 30U (n=30)

Study 3 (n=5, split-face):
  • •

    AboBoNT-A 48U

  • •

    OnaBoNT-A 16U

 AboBoNT-A 50U
OnaBoNT-A 20U
Patient numbers by treatment group were not provided.		 AboBoNT-A 50U (n=29)
OnaBoNT-A 20U (n=30)
MUSCLE TARGET Study 1: Glabellar region
Study 3: Bilateral lateral canthal lines		 Procerus and corrugator muscles Procerus muscle and corrugator muscle
MEASURE OF DURATION Study 1: Investigator-assessed Facial Wrinkle Severity (score for upper facial lines at maximum contraction, where none=0, mild lines=1, moderate lines=2, and severe lines=3).
Study 3: A photographic computerized wrinkle evaluation system, VISIA, was used to evaluate the severity of lateral canthal lines at smile.		 Investigator-assessed severity of glabellar lines at maximum frown, rated as none, mild, moderate, or severe (blinded photographic assessment). Patients with ratings of none or mild were considered responders.
Patient evaluation of global improvement used the following rating scale: complete improvement (100%), substantial improvement (75%), definite improvement (50%), some improvement (25%), unchanged, slight worsening (25%), moderate worsening (50%), and marked worsening (75%)		 Investigator-assessed improvement of ≥1 grade in glabellar line severity (none, mild, moderate, or severe) at maximum contraction (photographic assessment). Incidence of patients with a score of none or mild at maximum contraction and incidence of relapse (return to baseline severity at 2 consecutive visits) were also assessed.
ASSESSMENT TIME POINTS AFTER 12 WEEKS Study 1: Week 16 and 20
Study 3: Month 6		 Weeks 16 and 20 Week 16
RESULTS RELEVANT TO DURATION Facial wrinkle severity score for glabellar lines at Week 16 and 20:
  • •

    AboBoNT-A: 2.40 and 2.60, respectively

  • •

    OnaBoNT-A: 2.60 and 2.74, respectively

(Baseline value in both groups was 3.0)
No significant differences were observed between products at any time point.
Values estimated from figure
Percentage change from baseline in lateral canthal lines severity, assessed by photographic computerized line measurement at Month 6 post-injection:
  • •

    AboBoNT-A: 28%

  • •

    OnaBoNT-A: 30%

Values estimated from figure		 Proportion of patients remaining relapse-free at Week 16 and 20:
  • •

    AboBoNT-A: 55% and 45%, respectively

  • •

    OnaBoNT-A: 90% and 65%, respectively

Values estimated from figure
Relapse was not defined.
Proportion of responders by photographic examination at maximum frown at Week 16 and 20:
  • •

    AboBoNT-A: 14% and 7%, respectively

  • •

    OnaBoNT-A: 20% and 13%, respectively

Values estimated from figure
Patient evaluation of improvement in glabellar lines at Week 16 and 20:
  • •

    AboBoNT-A: 8% and 14%, respectively

  • •

    OnaBoNT-A: 33% and 27%, respectively

 Patients with ≥1-grade improvement at Week 16:
  • •

    AboBoNT-A: 28%

  • •

    OnaBoNT-A: 53%

p=0.04 in favor of onaBoNT-A
Patients with a score of none or mild at Week 16 at maximum contraction:
  • •

    AboBoNT-A: 10%

  • •

    OnaBoNT-A: 23%

No significant difference
Incidence of relapse by Week 16:
  • •

    AboBoNT-A: 40%

  • •

    OnaBoNT-A: 23%
SPONSOR Not specified Allergan, Inc. Allergan, Inc. (research grant)
STUDY Michaels 201230 Nestor 201145 Rappl 201326
INDICATION Forehead, glabellar and periorbital wrinkles (N=53) Frontalis lines (N=20) Glabellar lines (N=180)
STUDY DESIGN Prospective, randomized, double-blind, split-face study versus onaBoNT-A Randomized, double-blind, split face versus onaBoNT-A Randomized, double-blind, single-center, comparator-controlled (onaBoNT-A and incoBoNT-A)
TREATMENT AboBoNT-A 62.5U
OnaBoNT-A 25U		 AboBoNT-A 25U (5U in each injection point) OnaBoNT-A 10U (2U in each of 5 injection points) Total dose administered:
  • •

    21U incoBoNT-A (n=60)

  • •

    21U onaBoNT-A (n=59)

  • •

    63U aboBoNT-A (n=60)
MUSCLE TARGET Forehead frown lines, the glabellar area, and lateral canthal lines Contralateral sides of frontalis Procerus
Left and right medial corrugators
Left and right lateral corrugators
MEASURE OF DURATION Fitzpatrick wrinkle grading scale (0, absence of wrinkles to 3, deep furrow of ≥3mm in depth; at 0.5 grade intervals)
VISIA computerized wrinkle grading system and eyebrow height during first week post-injection
Forehead, glabellar and periorbital wrinkles were also graded on individual scales		 Duration of effect was assessed using the frontalis rating scale 4-point scale from 0 (none)-3 (severe) as well as frontalis activity measurement defined in terms of percentage change in frontalis muscle activity determined by measuring the difference between the height of the frontalis at maximum elevation and at rest. Measurements and calculations were performed by a blinded assistant investigator.
Partial efficacy (≥1-point change in frontalis rating scale scores or 20% change in frontalis activity measurement standard), full efficacy (≥2-point change in frontalis rating scale scores or 33% change in frontalis activity measurement standard and complete efficacy (3-point change in frontalis rating scale scores or ≥66% change in frontalis activity measurement standard) were recorded.		 Time to return to baseline muscle activity (video assessment)
ASSESSMENT TIME POINTS AFTER 12 WEEKS Days 90, 105 120, 135, and 150 Days 90, 105, 120, 135, 150, 165, 180, 195, and 210 Study visits at days 90, 120, 150, and 180
RESULTS RELEVANT TO DURATION Percentage of patients showing improvement at Days 90, 120, and 150 in the forehead region:
  • •

    AboBoNT-A: 75%, 74%, and 64%, respectively

  • •

    OnaBoNT-A: 72%, 68%, and 60%, respectively

Percentage of patients showing improvement at Days 90, 120, and 150 in the glabellar region:
  • •

    AboBoNT-A: 60%, 54%, and 43%, respectively

  • •

    OnaBoNT-A: 56%, 41%, and 45%, respectively

Percentage of patients showing improvement at Days 90, 120, and 150 in the periorbital region:
  • •

    AboBoNT-A: 49%, 32%, and 28%, respectively

  • •

    OnaBoNT-A: 43%, 26%, and 34%, respectively

No statistically significant differences were observed between aboBoNT-A and onaBoNT-A.
Average Fitzpatrick scores for forehead, glabellar and periorbital regions, as well as Visia average score for overall number of wrinkles did not return to baseline values by Day 150.		 Median duration of partial, full and complete efficacy by frontalis rating scale assessment:
  • •

    AboBoNT-A: 160 days, 119 days, and 63 days, respectively

  • •

    OnaBoNT-A: 145 days, 77 days, and 44 days, respectively

p=0.003 andp=0.01 in favor of aboBoNT-A for full and complete efficacy, respectively
Median duration of patient, full and complete efficacy by frontalis activity measurement standard assessment:
  • •

    AboBoNT-A: 105 days, 103 days and 72 days, respectively

  • •

    OnaBoNT-A: 99 days, 87 days, and 56 days, respectively

p=0.006, p=0.003, and p=0.01 in favor of aboBoNT-A for partial, full, and complete efficacy, respectively.		 Median duration of treatment effect
Male patients (n=27):
  • •

    AboBoNT-A: 115.81 days

  • •

    IncoBoNT-A: 121.14 days

  • •

    OnaBoNT-A: 116.61 days

Female patients (n=152):
  • •

    AboBoNT-A: 139.69 days

  • •

    IncoBoNT-A: 146.12 days

  • •

    OnaBoNT-A: 140.65 days

Sex was the primary predictor of treatment duration (p<0.0001). Treatment identity had only a small influence (p=0.0735).
Eight subjects (aboBoNT-A, n=2; incoBoNT-A, n=4; onaBoNT-A, n=2) showed an effect at day 180.
SPONSOR None Medicis Aesthetics Inc. (research grant) Not specified. Editorial assistance funded by Merz.
FIRST AUTHOR Sapra 201754 Saybel 201550 Wilson 201635
INDICATION Glabellar, forehead and periorbital wrinkles (N=10) Lateral canthal lines (N=20) Glabellar rhytides (N=73)
STUDY DESIGN Single-blind, split-face, randomized study of intradermal and intramuscular injections of aboBoNT-A and onaBoNT-A Randomized, rater-blinded, split-face study Randomized, double-blind, prospective study versus incoBoNT-A and onaBoNT-A
TREATMENT Average doses administered:
  • •

    OnaBoNT-A 76.5U (n=5; intradermal at Week 0, 50U; intramuscular at Week 2, 26.5U)

  • •

    AboBoNT-A 189.5U (n=5; intradermal at Week 0, 125U; intramuscular at Week 2, 64.5U)

 AboBoNT-A 27U (left side)
IncoBoNT-A 9U (right side)		 AboBoNT-A 60U (n=25)
OnaBoNT-A 20U (n=23)
IncoBoNT-A 20U (n=25)
MUSCLE TARGET Glabellar, forehead, periorbital, perioral, and cheek regions (muscles not specified) Orbicularis oculi Corrugator and procerus muscles
MEASURE OF DURATION Blinded-evaluator assessment of wrinkle severity using post-treatment photographs taken using VISIA Complexion Analysis System, Vectra® 3D imaging software, and a handheld digital camera Investigator assessment of wrinkles on a 5-point Merz Aesthetic Scale (0=no wrinkles; 1=mild wrinkles; 2=moderate wrinkles; 3=severe wrinkles; 4=very severe wrinkles), using standardized photographs. Response was defined as a ≥1-point improvement from baseline.
Patient self-assessment of wrinkle severity on a 9-point global assessment scale from -4 (very strong worsening of lateral canthal lines) to +4 (very strong improvement of lateral canthal lines).		 Horizontal strain reduction measured via digital image correlation software (ARAMIS)
ASSESSMENT TIME POINTS AFTER 12 WEEKS Week 16 Month 4 and 6 Day 90
RESULTS RELEVANT TO DURATION Median change in wrinkles in the forehead region at Week 16:
  • •

    Overall: -0.67 (p=0.014 vs. baseline)

  • •

    AboBoNT-A: -0.67

  • •

    OnaBoNT-A: -0.67

Median change in wrinkles in the glabellar region at Week 16:
  • •

    Overall: -0.67 (p=0.014 vs. baseline)

  • •

    AboBoNT-A: -0.11

  • •

    OnaBoNT-A: -0.11

Median change in wrinkles in the periorbital region at Week 16:
  • •

    Overall: -0.44

  • •

    AboBoNT-A: -1.0

  • •

    OnaBoNT-A: -1.0

No significant differences between products		 Merz Aesthetic Score at maximum contraction at Month 4 and Month 6:
  • •

    AboBoNT-A: 1.26 and 1.88, respectively

  • •

    IncoBoNT-A: 1.23 and 1.84, respectively

All scores were p<0.05 versus baseline
Proportion of responders at maximum contraction at Month 4 and Month 6:
  • •

    AboBoNT-A: 83% and 61%, respectively

  • •

    IncoBoNT-A: 83% and 67%, respectively

Merz Aesthetic Score at rest at Month 4 and Month 6:
  • •

    AboBoNT-A: 0.50 and 1.00, respectively

  • •

    IncoBoNT-A: 0.50 and 0.90, respectively

All scores were p<0.05 versus baseline.
Proportion of patients reporting moderate, significant, and very significant improvement in wrinkle severity:
  • •

    AboBoNT-A Month 4: 78%, 5%, and 11%, respectively

  • •

    AboBoNT-A Month 6: 61%, 11%, and 0%, respectively

  • •

    IncoBoNT-A Month 4: 83%, 11%, and 6%, respectively

  • •

    IncoBoNT-A Month 6: 56%, 11%, and 0%, respectively

 Percentage strain reduction at Day 90 post-injection:
  • •

    AboBoNT-A: 38.4%

  • •

    OnaBoNT-A: 43.5%

  • •

    IncoBoNT-A: 25.3%

No significant differences were observed between toxins at this time point (p=0.27).
SPONSOR None Merz Pharmaceuticals GmbH (funding for editorial assistance, full funding not described). The Center for Human Appearance at the University of Pennsylvania