TABLE 4.
Duration of response—single cycle, uncontrolled studies
| STUDY | Fabi 201324 | Farahvash 200722 | Hexsel 200952 | Dubina 201346 |
| INDICATION | Lateral canthal rhytides (N=40) | Glabellar lines, frontal lines and lateral canthal lines (N=115) | Glabellar wrinkles (N=105) | Glabellar and forehead lines (N=20) |
| STUDY DESIGN | Uncontrolled (two-center, prospective, evaluator-blinded, open-label, randomized, comparative, split-face study [one vs. three injection sites]) | Uncontrolled (single-arm prospective study) | Uncontrolled, randomized, multicenter, blinded study | Split-face, randomized controlled trial |
| TREATMENT | Total dose:
|
Average units per site per injection:
|
AboBoNT-A 50U Patients were randomized to 3 groups, each receiving injections diluted at 15 days, 8 days, and 8 hours prior to injections |
AboBoNT-A, up to 65U AboBoNT-A, up to 65U + hyaluronic acid filler, up to 1mL |
| MUSCLE TARGET | Lateral orbital/canthal area | Corrugators, frontalis, lateral orbicularis oculi | Corrugators and procerus muscles | Bilateral forehead and glabella |
| MEASURE OF DURATION | Maximal contraction of lateral periocular rhytides measured by a blinded investigator using a 4-point Photographic scale (0=no wrinkles; 1=mild wrinkles; 2=moderate wrinkles; 3=severe wrinkles). | Wrinkle improvement was assessed on a scale ranging from 0 (no improvement) to 3 (significant improvement), evaluated by investigators based on pre- and post-injection photographs | Investigator-, patient- and specialist-assessed motility of the treated area using a four-point qualitative scale (1, unaltered; 2, slightly reduced; 3, moderately reduced; 4, very reduced), at each visit. | Glabellar wrinkles were rated on a 4-point scale. Forehead wrinkle ratings on a 5-point scale. Photographs were rated by two blinded dermatologists. A 1-point improvement was considered improved and a >1-point improvement was markedly improved. Assessments were made for dynamic (lines induced by contraction) and static (lines persisting at rest) wrinkles. Patient evaluation of improvement compared with baseline in wrinkle look and feel were also reported |
| ASSESSMENT TIME POINTS AFTER 12 WEEKS | Day 120 (Week 16) | Months 3, 4, 5, 6, and 7 | Day 112 | Week 24 |
| RESULTS RELEVANT TO DURATION | Reduction from baseline in investigator-assessed wrinkle score at Day 120:
|
Degree of wrinkle improvement from baseline at Month 3, 4, and 5 (n=108):
|
Average motility scores at Day 112 for injections reconstituted at 8 hours, 8 days, and 15 days prior to injection:
|
Percentage of patients improved and markedly improved at Week 24 in the aboBoNT-A only group (dermatologist assessment):
|
| SPONSOR | Medicis | None | Ipsen (research grant to the Brazilian Center for Studies in Dermatology) | Medicis Aesthetics Inc. (research grant) |
| STUDY | Hexsel 201347 | Joseph 201648 | Karbassi 201821 | |
| INDICATION | Full-face wrinkles (N=90) | Glabellar lines (N=30) | Glabellar lines (N=104) | |
| STUDY DESIGN | Prospective, single-center, randomized, open-label study of full-face injections of three different doses of aboBoNT-A | Investigator-initiated, prospective, multicenter, open-label study | Uncontrolled (cross sectional, descriptive study) | |
| TREATMENT | Group 1 (n=26):
|
AboBoNT-A 120U (equal doses into 5 injection sites) | AboBoNT-A 45–60U (10–20U per injection point) | |
| MUSCLE TARGET | Upper face:
|
Corrugators and procerus muscle | Corrugator muscles | |
| MEASURE OF DURATION | Clinical 0–3 scoring for glabellar frown lines, photonumeric atlas for the assessment of lateral canthal lines severity and Forehead Wrinkle Severity scales were used for wrinkle assessment in these areas. | Investigator’s assessment at maximum frown using a 4-point categorical assessment at each time point following treatment compared with the baseline assessment. Subject satisfaction was also assessed. | Glabellar Line Severity Score (0 stands for none, 1 for mild, 2 for moderate, and 3 for severe glabellar lines) assessed at rest and maximum frown (photographic assessment). Responders were defined as patients with none or mild glabellar lines. | |
| ASSESSMENT TIME POINTS AFTER 12 WEEKS | Weeks 16, 20, and 24 | Day 90, 120, 150, 180, 210, 240, 270, and 300 (or end-of-study, whichever was soonest) | Day 120 and 180 | |
| RESULTS RELEVANT TO DURATION | Estimated mean values of forehead wrinkle severity assessment scores at Week 16, 20 and 24 post-injection:
Statistically significant reductions in the wrinkle scores were seen only at 16 weeks for forehead and lateral canthal lines wrinkles (all p<0.001, with no difference between the groups), although clinical effects were observed at Week 24. Statistically significant improvement was seen in glabellar lines, with results lasting more than 24 weeks (all p<0.001, with no difference between the groups). |
Percentage of patients with a ≥1 grade improvement of glabellar lines at maximum frown (investigator’s assessment):
|
Responders (percentage of patients with no or mild wrinkles) at Days 120 and 180:
Durability is not defined. |
|
| SPONSOR | Galderma (research grant) | Galderma | Not specified | |
| STUDY | Kiripolsky 201131 | Punga 201617 | ||
| INDICATION | Facial rhytides (N=185) | Glabellar lines (N=62) | ||
| STUDY DESIGN | Uncontrolled (retrospective, single-site, two-phase study) | Multicenter, randomized, comparative study of aboBoNT-A at 2 injection volumes | ||
| TREATMENT | Phase 1:
|
AboBoNT-A 50U: Injection volumes 0.05mL (n=30) and 0.1mL (n=32) per injection point | ||
| MUSCLE TARGET | According to patient need: lateral canthal lines, depressor anguli oris, frontalis, glabella, nasalis, mentalis, and platysmal bands | Procerus and corrugator muscles | ||
| MEASURE OF DURATION | Efficacy (duration of action) as measured by questionnaire in the clinic and during telephone follow ups (duration of action: subjects described time from onset of relaxation until complete and full activity of muscle activity). | Wrinkle severity at maximum frown using 5-grade, validated scale performed both live and by a blinded independent evaluator. Compound muscle action potential using electroneurography at one site. | ||
| ASSESSMENT TIME POINTS AFTER 12 WEEKS | Week 16 | Month 3, 4, and 6 | ||
| RESULTS RELEVANT TO DURATION | Patients reporting therapeutic activity at Week 16 post-injection:
|
Percentage of patients showing a ≥1 grade improvement in wrinkle severity at maximum frown on Month 3, 4, and 6 (investigator assessment):
|
||
| SPONSOR | None | Galderma (supply of equipment and product) |
AboBoNT-A, abobotulinumtoxinA; incoBoNT-A, incobotulinumtoxinA; onaBoNT-A, onabotulinumtoxinA