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. 2020 Dec 1;13(12):E56–E83.

TABLE 2.

Duration of response—single-cycle, placebo-controlled studies

STUDY Ascher 200937 Ascher 200438 Ascher 201823 Brandt 200915
INDICATION Lateral canthal lines (N=220) Glabellar lines (N=119) Glabellar lines (N=176) Glabellar lines (N=158)
STUDY DESIGN Multicenter, randomized, double-blind, parallel-group, placebo-controlled study Multicenter, randomized, double-blind, placebo-controlled study Phase II, randomized, multicenter, double-blind, placebo and active comparator (aboBoNT-A) controlled study of new abobotulinumtoxinA solution for injection (ASI) Prospective, randomized, double-blind, placebo-controlled, parallel-group, Phase III trial
TREATMENT Total dose administered:
  • •

    AboBoNT-A 15U (n=42)

  • •

    AboBoNT-A 30U (n=37)

  • •

    AboBoNT-A 45U (n=40)

  • •

    Placebo (n=43)

 Total dose administered: AboBoNT-A 25U (n=34)
  • •

    AboBoNT-A 50U (n=34)

  • •

    AboBoNT-A 75U (n=34)

  • •

    Placebo (n=17)

 Placebo (n=35)
ASI 20U (n=36)
ASI 50U (n=35)
ASI 75U (n=35)
AboBoNT-A 50U (n=35)		 AboBoNT-A 50U (n=105)
Placebo (n=53)
MUSCLE TARGET Lateral canthal lines Procerus and depressor supercilii and two injection points in the inner first and second thirds of each corrugator Procerus, corrugator, and lateral corrugator/orbicularis muscle Five injection points across the glabellar region
MEASURE OF DURATION Percentage of responders, defined as improvement in severity of lateral canthal lines from moderate or severe (Grade 2 or 3) at baseline to none or mild (Grade 0 or 1) on both sides at maximum smile. Assessed by independent panel based on standardized photographs, and investigator assessed. Percentage of responders defined as patients with grade 0 or 1 glabellar line (standardized severity scale of 0=none to 3=severe) at rest, as determined from standardized digital photographs. Four-point glabellar line severity scale. Response defined as a score of none (0) or mild (1) (all subjects were moderate [2] or severe [3] at baseline) by investigator and subject assessment. Responders at maximum from by investigator (severity grade of none [0] or mild [1] on a 4-point photographic glabellar line severity scale) assessment.
Subject self-assessment was also performed on a 4-point categorical scale of 0 (no wrinkles), 1 (mild wrinkles), 2 (moderate wrinkles), 3 (severe wrinkles).
ASSESSMENT TIME POINTS AFTER 12 WEEKS Weeks 12, 16, 20, 24 Days 90 and 180 Day 85 and 113 Day 90, 120, 150, and 180
RESULTS RELEVANT TO DURATION Percentage of responses at maximum smile (independent panel-assessed) at Week 12, 16, 20, and 24:
  • •

    aboBoNT-A 15U: 16%, 16%, 8%, and 8%, respectively

  • •

    aboBoNT-A 30U: 40%, 23%, 21%, 16%, respectively

  • •

    aboBoNT-A 45U: 37%, 20%, 10%, and 16%, respectively

  • •

    Placebo: 9%, 7%, 2%, and 11%, respectively

p<0.05 versus placebo for aboBoNT-A 30U and 45U at Week 12
Percentage of responses at maximum smile (investigator-assessed) at Week 12, 16, 20, and 24:
  • •

    aboBoNT-A 15U: 25%, 6%, 0%, and 0%, respectively

  • •

    aboBoNT-A 30U: 29%, 23%, 14% and 11%, respectively

  • •

    aboBoNT-A 45U: 29%, 13%, 5%, and 4%, respectively

  • •

    Placebo: 2%, 0%, 0%, and 2% respectively

p≤0.01 versus placebo for all aboBoNT-A doses at Week 12
Values derived from figure		 Percentage of responders at rest (investigator-assessed) at Day 90 and 180:
  • •

    AboBoNT-A 25U: 64.3% and 34.5%, respectively

  • •

    AboBoNT-A 50U: 75.9% and 31.0%, respectively

  • •

    AboBoNT-A 75U: 72.4% and 37.9%, respectively

  • •

    Placebo: 6.7% and 6.7%, respectively

p<0.001 versus placebo for all aboBoNT-A doses at Day 90
Percentage of responders at maximum frown (investigator-assessed) at Day 90 and 180:
  • •

    AboBoNT-A 25U: 32.1% and 13.8%, respectively

  • •

    AboBoNT-A 50U: 48.3% and 13.8%, respectively

  • •

    AboBoNT-A 75U: 51.7% and 10.3%, respectively

  • •

    Placebo: 0% and 0%, respectively

p<0.016 versus placebo for all aboBoNT-A doses at Day 90		 Proportion of responders at Day 85 and 113:
Investigator’s live assessment:
  • •

    AboBoNT-A 50U: 52.9% and 31.4%, respectively

  • •

    ASI 20, 50 and 70U: 48.5–75.0% and 22.2–55.9%, respectively

  • •

    Placebo: 0.0% at both time points

Subject self-assessment:
  • •

    AboBoNT-A 50U: 52.9%, and 28.6%, respectively

  • •

    ASI 20, 50 and 70U: 48.5–75.0% and 36.1–52.9%, respectively

  • •

    Placebo: 0.0% at both time points

 Percentage of responders at maximum frown (investigator’s assessment) at Day 90, 120, 150 and 180:
  • •

    AboBoNT-A 50U: 46.4%, 24.2%, 9.5%, and 6.3%, respectively

  • •

    Placebo: 6.4%, 4.1%, 2.2%, and 0.0%, respectively

p<0.001 at Day 90 and p=0.002 at Day 120
Percentage of responders at maximum frown (subject self-assessment) at Day 90, 120, 150, and 180:
  • •

    AboBoNT-A 50U: 39.2%, 20.2%, 8.3%, and 7.3%, respectively

  • •

    Placebo: 6.4%, 6.1% 4.4%, and 8.7%, respectively

p<0.001 at Day 90 and p=0.03 at Day 120
SPONSOR Ipsen, Ltd Beaufour Ipsen Pharma SAS Ipsen Medicis Aesthetics, Inc.
STUDY Kane 200916 Monheit 200725 Rzany 200639
INDICATION Glabellar lines (N=816) Glabellar lines (N=373) Glabellar lines and central forehead wrinkles (N=221)
STUDY DESIGN Phase III, double-blind, placebo-controlled trial Randomized, double-blind, multicenter, placebo-controlled study Multicenter, double-blind, placebo-controlled, randomized, 16-week trial
TREATMENT AboBoNT-A (n=544) or placebo (n=272)
Women received aboBoNT-A 50, 60, or 70U
Men received aboBoNT-A 60, 70, or 80U		 AboBoNT-A 20U (n=91)
AboBoNT-A 50U (n=93)
AboBoNT-A 75U (n=95)
Placebo (n=94)		 AboBoNT-A 30U, 3 injections (n=73)
Placebo, 3 injections (n=37)
AboBoNT-A 50U, 5 injections (n=73)
Placebo, 5 injections (n=38)
MUSCLE TARGET Procerus, corrugator, lateral corrugator/orbicularis Procerus, corrugator supercilii, and orbicularis muscles Medial corrugator muscles and procerus muscle
In Study Arm 2 (aboBoNT-A 50U), 2 cranial sites covering part of the frontalis muscle
MEASURE OF DURATION Live assessment by a blinded evaluator and patient self-assessment at maximum frown using the 4-point Glabellar Line Severity Score.
Responders were defined as patients with a score of 2 or 3 at baseline and a score of 0 or 1 following injection.		 Investigator’s live assessment of glabellar lines, at maximum frown and at rest. Each scale comprised four photographs graded 0 to 3: Grade 0=none, Grade 1=mild, Grade 2=moderate, or Grade 3=severe; responder was defined as a participant who had a rating of 0 or 1. Number (rate) of responders on a 4-point standardized clinical scale (0=no wrinkles; 1=mild wrinkles; 2=moderate wrinkles; and 3=severe wrinkles), using standardized digital photographs, by a committee of 4 investigators
ASSESSMENT TIME POINTS AFTER 12 WEEKS Days 90, 120, and 150 Day 90 and 120 Week 16
RESULTS RELEVANT TO DURATION Kaplan-Meier estimates for the probability of being a responder at Day 90, 120 and 150 (investigator assessment):
  • •

    AboBoNT-A: 0.603, 0.383, and 0.155, respectively.

  • •

    Placebo: 0.007, 0.004, and 0.004, respectively.

Mean (SD) duration of response:
  • •

    AboBoNT-A: 94.0 (49.2) days

  • •

    Placebo: 3.3 (14.9) days

  • •

    p<0.001

Kaplan-Meier estimates for the probability of being a responder at Day 90, 120 and 150 (subject assessment):
  • •

    AboBoNT-A: 0.606, 0.387, and 0.157, respectively

  • •

    Placebo: 0.026, 0.018, and 0.015, respectively

Mean (SD) duration of response:
  • •

    AboBoNT-A: 92.8 (50.9) days

  • •

    Placebo: 5.6 (23.4) days

  • •

    p<0.001

 Proportion of responders at maximum frown (investigator’s assessment):
  • •

    AboBoNT-A 20U: significant versus placebo up to Day 90 (p=0.004)

  • •

    AboBoNT-A 50U and 75U: 26% and 27%, respectively at Day 120

  • •

    Significant versus placebo for all time points (up to Day 120;p<0.001 for all comparisons)

  • •

    Some patients assessed as having no decline in benefit at maximum frown on Day 120: AboBoNT-A 20U, n=3; aboBoNT-A 50U, n=8; aboBoNT-A 75U, n=7

Proportion of responders at rest (investigator’s assessment):
  • •

    p≤0.001 to 0.01 for all comparisons of aboBoNT-A (20U, 50U, and 75U) versus placebo

Proportion of responders at maximum frown (patient assessment):
  • •

    AboBoNT-A 20U: 20% at Day 120.p<0.001 up to Day 90,p=0.005 at Day 120

  • •

    AboBoNT-A 50U and 75U: 42% and 51%, respectively.p<0.001 versus placebo at all time points (up to Day 120)

Some patients assessed as having no decline in benefit at maximum frown on Day 120: AboBoNT-A 20U, n=2; aboBoNT-A 50U, n=7; aboBoNT-A 75U, n=12		 Proportion of patients with a score of 0 and 1 at maximum frown at Week 16 post-injection:
  • •

    AboBoNT-A 30U: 0% and 13.2%, respectively

  • •

    Placebo (3 injections): 0% and 2.9%, respectively

  • •

    AboBoNT-A 50U: 1.4% and 26.0%, respectively

  • •

    Placebo (five injections): 0% and 2.6%, respectively

Proportion of patients with a score of 0 and 1 at rest at Week 16 post-injection:
  • •

    AboBoNT-A 30U: 17.6% and 64.7%, respectively

  • •

    Placebo (3 injections): 5.7% and 45.7%, respectively

  • •

    AboBoNT-A 50U: 13.7% and 65.8%, respectively

  • •

    Placebo (5 injections): 0% and 73.7%, respectively
SPONSOR Medicis Aesthetics This study was a Phase II FDA investigation and was supported by funds from Ipsen Biopharm Limited and Inamed Corporation. Ipsen Pharma

AboBoNT-A, abobotulinumtoxinA; incoBoNT-A, incobotulinumtoxinA; onaBoNT-A, onabotulinumtoxinA.