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IncobotulinumtoxinA versus onabotulinumtoxinA in the treatment of glabellar facial lines: Results from a multicenter, randomized, double-blinded trial
3526
3048
IncobotulinumtoxinA versus onabotulinumtoxinA in the treatment of glabellar facial lines: Results from a multicenter, randomized, doubleblinded trial Michael Kane, MD, Manhattan Eye, Ear & Throat Hospital, New York, NY, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; William Coleman, MD, Tulane Health Sciences Center, Tulane University, New Orleans, LA, United States; Derek Jones, MD, Skin Care and Laser Physicians of Beverly Hills, Beverly Hills, CA, United States; Emil Tanghetti, MD, Center for Dermatology and Laser Surgery, Sacramento, CA, United States; Tina Alster, MD, Washington Institute of Dermatologic Laser Surgery, Washington, DC, United States; Tom Rohrer, MD, Skin Care Physicians, Chestnut Hill, MA, United States; Cheryl Burgess, MD, Center for Dermatology and Dermatologic Surgery, Sacramento, CA, United States; Ava Shamban, MD, University of California Los Angeles, Los Angeles, CA, United States
Isotretinoin and lasers: Friends or foes Minal Patwardhan Andrade, MD, MBBS, Minal Specialised Clinic Dermatology, Sharjah, United Arab Emirates Introduction: Traditionally lasers are avoided in patients on oral isotretinoin treatment. Most of the literature suggests that laser should be done approximately 6 months after stoppage of medication due to the belief that it may lead to scarring and delayed healing. Background: In our center, we have been doing laser for hair reduction on patients taking oral isotretinoin since more than 13 years. Over these many years approximately 10% of our patients of laser hair reduction were at some point of time on isotretinoin therapy and were subjected to the procedure. Initially lower fluences for patients on oral isotretinoin were used as a conservative approach. Later on, laser settings were kept similar to as when they were not on isotretinoin therapy. Acne scar resurfacing with long pulsed Nd:YAG laser, affirm laser and microfractional erbium glass laser have been used on patients in our center while on oral Isotretinoin since the past 7 years. Q-switched YAG lasers have also been used on our patients since its introduction in our set up.
The purpose of this study was to evaluate the efficacy of incobotulinumtoxinA at the FDA-recommended dose of 20 units (U) for the treatment of glabellar facial lines (GFLs), when compared to onabotulinumtoxinA. This randomized, double-blind, parallel-group study evaluated 250 females with moderate-to-severe GFLs on the Facial Wrinkle Scale (FWS). Subjects were randomized 1:1 to incobotulinumtoxinA (N ¼ 122) or onabotulinumtoxinA (N ¼ 128). All subjects were treated with a single 20 U dose injected into the glabellar complex at 5 injection points. Injection volume was 0.5 mL of botulinum toxin type A reconstituted with 1.25 mL sterile, preservative-free, 0.9% sodium chloride injection, USP. Subjects returned for visits at 1, 2, 3, and 4-months postinjection. The primary endpoint was defined as a $1point improvement from baseline on the FWS at maximum frown 1-month posttreatment as rated by independent panel review (IPR) using standardized subject photographs. In order to determine the equivalence of treatment effect for incobotulinumtoxinA and onabotulinumtoxinA, a difference (D) in response rates (ie, $1-point improvement from baseline on the FWS) was obtained. The margin of equivalence based on clinical judgment was 15%. A two-sided 95% Newcombe-Wilson confidence interval (CI) was computed around the difference in response to treatment between incobotulinumtoxinA and onabotulinumtoxinA treatment groups. Secondary endpoints were $1-point improvement at all visits as assessed by IPR and by treating investigator; subject assessment of treatment satisfaction at all visits; subject reported date of onset and peak effect. Safety was assessed by recording all AEs. The primary endpoint was met with 95.7% and 99.2% of subjects achieving $1-point improvement in the incobotulinumtoxinA and onabotulinumtoxinA treatment groups, respectively. Equivalence was demonstrated with a D (95% CI) of: -3.5% (-7.5% to 0.6%). Similar efficacy profiles were demonstrated at all timepoints. Subject reported satisfaction, treatment onset, and peak effect were similar between the groups. Among all subjects, 11.5% of incobotulinumtoxinA subjects and 14.1% of onabotulinumtoxinA subjects experienced at least 1 AE with headache as the most common. There was no difference in safety profiles between the groups. The results from this study demonstrate that incobotulinumtoxinA and onabotulinumtoxinA result in similar efficacy and safety profiles for the treatment of GFLs.
Study: We hereby present a retrospective analysis of data over the last 5 years of patients who have undergone various laser procedures while being on isotretinoin therapy. The data have been collected from both our centers over different period of time. A total of 408 patients over the above said period underwent some sort of laser procedures concurrent with the oral therapy. With hair reduction lasers there were no untoward side effects. The degree of erythema, perifollicular edema, sensitivity were comparable to those not on isotretinoin therapy. With scar lasers the results have been comparable and/or better to those not on oral isotretinoin without any major complications. Conclusion: This experience over extended period of time in our practice suggests that laser therapy for hair reduction - alexandrite, LP Nd:YAG, Q-switched YAG laser and scar reduction using LP Nd:YAG, fractionated lasers is a safe option in patients on isotretinoin therapy. Commercial support: None identified.
Supported 100% by Merz North America, Inc.
3533 Independent photographic evaluation of small particle, hyaluronic acid gel plus lidocaine (SPHAL) on lip smoothness when performing lip augment Alessandra Nogueria, MD, Galderma Laboratories, LP, Fort Worth, TX, United States; Jay Mashburn, PhD, Galderma Laboratories, LP, Fort Worth, TX, United States Background: Full and smooth lips are often associated with youthfulness and facial beauty. Over time, lips become thinner with wrinkles and fine lines that can appear in both perioral and vermillion areas. Fine lines in the lips vermillion area can occur as a result of the aging process, the loss of volume, and dehydration, compromising the lips’ smooth appearance. Objective: Posthoc evaluation of the effect of Restylane Silk (Galderma Laboratories, LP), a small particle, hyaluronic acid gel plus lidocaine (SPHAL), on combined vermilion lip smoothness following lip augmentation, compared to no treatment control, at 8 weeks.
3754
Patient/methods: Two independent, blinded raters evaluated paired photographs from the SPHAL pivotal trial (one baseline image and one randomly displayed post baseline image at week 8, 12, 16, 20, or 24) for improvement in smoothness of vermillion lip lines. Upper and lower lips were assessed independently. Combined vermillion lip smoothness responders were defined as subjects with both the upper and lower lips rated as ‘‘improvement in lip smoothness’’ at week 8. This combined analysis was based on subjects who had both lips treated for fullness at baseline in the SPHAL pivotal trial. The degree of interrater agreement was determined by calculation of the kappa statistic. Results: SPHAL was significantly better than no treatment at 8 weeks as assessed by the blinded raters (75.5% vs 17.1%; P \ .001) for combined vermillion lips smoothness. SPHAL was also significantly better at weeks 12, 16, 20, and 24 compared to no treatment (P \.001) for combined vermillion lips smoothness. No safety analyses were performed. Interrater agreement between raters was substantial (weighted kappa ¼ 0.62). Conclusion: Posthoc photographic comparative evaluation pre- and posttreatment demonstrated the effectiveness of SPHAL for aesthetic improvement of lip smoothness. Supported by Galderma Laboratories, LP.
MAY 2016
J AM ACAD DERMATOL
AB19
3048
IncobotulinumtoxinA versus onabotulinumtoxinA in the treatment of glabellar facial lines: Results from a multicenter, randomized, doubleblinded trial Michael Kane, MD, Manhattan Eye, Ear & Throat Hospital, New York, NY, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; William Coleman, MD, Tulane Health Sciences Center, Tulane University, New Orleans, LA, United States; Derek Jones, MD, Skin Care and Laser Physicians of Beverly Hills, Beverly Hills, CA, United States; Emil Tanghetti, MD, Center for Dermatology and Laser Surgery, Sacramento, CA, United States; Tina Alster, MD, Washington Institute of Dermatologic Laser Surgery, Washington, DC, United States; Tom Rohrer, MD, Skin Care Physicians, Chestnut Hill, MA, United States; Cheryl Burgess, MD, Center for Dermatology and Dermatologic Surgery, Sacramento, CA, United States; Ava Shamban, MD, University of California Los Angeles, Los Angeles, CA, United States
Isotretinoin and lasers: Friends or foes Minal Patwardhan Andrade, MD, MBBS, Minal Specialised Clinic Dermatology, Sharjah, United Arab Emirates Introduction: Traditionally lasers are avoided in patients on oral isotretinoin treatment. Most of the literature suggests that laser should be done approximately 6 months after stoppage of medication due to the belief that it may lead to scarring and delayed healing. Background: In our center, we have been doing laser for hair reduction on patients taking oral isotretinoin since more than 13 years. Over these many years approximately 10% of our patients of laser hair reduction were at some point of time on isotretinoin therapy and were subjected to the procedure. Initially lower fluences for patients on oral isotretinoin were used as a conservative approach. Later on, laser settings were kept similar to as when they were not on isotretinoin therapy. Acne scar resurfacing with long pulsed Nd:YAG laser, affirm laser and microfractional erbium glass laser have been used on patients in our center while on oral Isotretinoin since the past 7 years. Q-switched YAG lasers have also been used on our patients since its introduction in our set up.
The purpose of this study was to evaluate the efficacy of incobotulinumtoxinA at the FDA-recommended dose of 20 units (U) for the treatment of glabellar facial lines (GFLs), when compared to onabotulinumtoxinA. This randomized, double-blind, parallel-group study evaluated 250 females with moderate-to-severe GFLs on the Facial Wrinkle Scale (FWS). Subjects were randomized 1:1 to incobotulinumtoxinA (N ¼ 122) or onabotulinumtoxinA (N ¼ 128). All subjects were treated with a single 20 U dose injected into the glabellar complex at 5 injection points. Injection volume was 0.5 mL of botulinum toxin type A reconstituted with 1.25 mL sterile, preservative-free, 0.9% sodium chloride injection, USP. Subjects returned for visits at 1, 2, 3, and 4-months postinjection. The primary endpoint was defined as a $1point improvement from baseline on the FWS at maximum frown 1-month posttreatment as rated by independent panel review (IPR) using standardized subject photographs. In order to determine the equivalence of treatment effect for incobotulinumtoxinA and onabotulinumtoxinA, a difference (D) in response rates (ie, $1-point improvement from baseline on the FWS) was obtained. The margin of equivalence based on clinical judgment was 15%. A two-sided 95% Newcombe-Wilson confidence interval (CI) was computed around the difference in response to treatment between incobotulinumtoxinA and onabotulinumtoxinA treatment groups. Secondary endpoints were $1-point improvement at all visits as assessed by IPR and by treating investigator; subject assessment of treatment satisfaction at all visits; subject reported date of onset and peak effect. Safety was assessed by recording all AEs. The primary endpoint was met with 95.7% and 99.2% of subjects achieving $1-point improvement in the incobotulinumtoxinA and onabotulinumtoxinA treatment groups, respectively. Equivalence was demonstrated with a D (95% CI) of: -3.5% (-7.5% to 0.6%). Similar efficacy profiles were demonstrated at all timepoints. Subject reported satisfaction, treatment onset, and peak effect were similar between the groups. Among all subjects, 11.5% of incobotulinumtoxinA subjects and 14.1% of onabotulinumtoxinA subjects experienced at least 1 AE with headache as the most common. There was no difference in safety profiles between the groups. The results from this study demonstrate that incobotulinumtoxinA and onabotulinumtoxinA result in similar efficacy and safety profiles for the treatment of GFLs.
Study: We hereby present a retrospective analysis of data over the last 5 years of patients who have undergone various laser procedures while being on isotretinoin therapy. The data have been collected from both our centers over different period of time. A total of 408 patients over the above said period underwent some sort of laser procedures concurrent with the oral therapy. With hair reduction lasers there were no untoward side effects. The degree of erythema, perifollicular edema, sensitivity were comparable to those not on isotretinoin therapy. With scar lasers the results have been comparable and/or better to those not on oral isotretinoin without any major complications. Conclusion: This experience over extended period of time in our practice suggests that laser therapy for hair reduction - alexandrite, LP Nd:YAG, Q-switched YAG laser and scar reduction using LP Nd:YAG, fractionated lasers is a safe option in patients on isotretinoin therapy. Commercial support: None identified.
Supported 100% by Merz North America, Inc.
3533 Independent photographic evaluation of small particle, hyaluronic acid gel plus lidocaine (SPHAL) on lip smoothness when performing lip augment Alessandra Nogueria, MD, Galderma Laboratories, LP, Fort Worth, TX, United States; Jay Mashburn, PhD, Galderma Laboratories, LP, Fort Worth, TX, United States Background: Full and smooth lips are often associated with youthfulness and facial beauty. Over time, lips become thinner with wrinkles and fine lines that can appear in both perioral and vermillion areas. Fine lines in the lips vermillion area can occur as a result of the aging process, the loss of volume, and dehydration, compromising the lips’ smooth appearance. Objective: Posthoc evaluation of the effect of Restylane Silk (Galderma Laboratories, LP), a small particle, hyaluronic acid gel plus lidocaine (SPHAL), on combined vermilion lip smoothness following lip augmentation, compared to no treatment control, at 8 weeks.
3754
Patient/methods: Two independent, blinded raters evaluated paired photographs from the SPHAL pivotal trial (one baseline image and one randomly displayed post baseline image at week 8, 12, 16, 20, or 24) for improvement in smoothness of vermillion lip lines. Upper and lower lips were assessed independently. Combined vermillion lip smoothness responders were defined as subjects with both the upper and lower lips rated as ‘‘improvement in lip smoothness’’ at week 8. This combined analysis was based on subjects who had both lips treated for fullness at baseline in the SPHAL pivotal trial. The degree of interrater agreement was determined by calculation of the kappa statistic. Results: SPHAL was significantly better than no treatment at 8 weeks as assessed by the blinded raters (75.5% vs 17.1%; P \ .001) for combined vermillion lips smoothness. SPHAL was also significantly better at weeks 12, 16, 20, and 24 compared to no treatment (P \.001) for combined vermillion lips smoothness. No safety analyses were performed. Interrater agreement between raters was substantial (weighted kappa ¼ 0.62). Conclusion: Posthoc photographic comparative evaluation pre- and posttreatment demonstrated the effectiveness of SPHAL for aesthetic improvement of lip smoothness. Supported by Galderma Laboratories, LP.
MAY 2016
J AM ACAD DERMATOL
AB19