A Comparison of The Efficacy and Safety of Incobotulin - 2013 - Journal of The A
A Comparison of The Efficacy and Safety of Incobotulin - 2013 - Journal of The A
A Comparison of The Efficacy and Safety of Incobotulin - 2013 - Journal of The A
Treatment of acne in children aged 9 to 11 with a fixed dose combination Treatment with adapalene-benzoyl peroxide improve quality of life in
of adapalene-benzoyl peroxide gel patients with severe acne vulgaris
Lawrence Eichenfield, MD, Rady Children’s Hospital San Diego, San Diego, CA, Robert T. Brodell, MD, Northeastern Ohio Medical University, Rootstown, OH,
United States; Adelaide A. Hebert, MD, Departments of Dermatology and United States; Albert Wertheimer, PhD, Temple University, Temple University, PA,
Pediatrics, University of Texas-Houston Medical School, Houston, TX, United United States; Darryl Toth, MD, XLR8 Medical Research, Inc, Windsor, Canada;
States; Anne W. Lucky, MD, Department of Pediatrics, Cincinnati Children’s Delphine Bucher, Galderma International, La Defense, France; Elyse Rafal, MD,
Hospital Medical Center, Cincinnati, OH, United States; Diane Rudisill, Galderma Derm Research Center of New York, Inc, Stony Brook, NY, United States; Nabil
Research and Development, Cranbury, NJ, United States; Jeffrey Sugarman, MD, Kerrouche, MMSc, Galderma Research and Development, Biot, France; Stephen
University of California, Santa Rosa, CA, United States; Linda Stein Gold, MD, Tyring, MD, Center for Clinical studies, Webster, TX, United States
Department of Dermatology, Henry Ford Health Systems, West Bloomfield, MI, Acne vulgaris is a common skin disease that can severely affect quality of life
United States; Zoe Draelos, MD, Dermatology Consulting Services, High Point, (QoL). Patients often have depressive symptoms, low self-esteem, and poor body
NC, United States image. The Acne-QoL questionnaire is a validated instrument that describes 4
Acne vulgaris is commonly observed in preadolescent children. However, most domains of QoL: self-perception, role-emotional, role-social, and acne symptoms.
topical therapies are indicated for patients aged 12 and older. A multicenter, Two related clinical trials investigated the use of a combination dose of
randomized, vehicle-controlled, double-blind study investigated a combination dose adapalene-benzoyl peroxide 0.1%/2.5% (A-BPO) in the treatment of acne vulgaris.
of adapalene-benzoyl peroxide 0.1%/2.5% (A-BPO) to treat acne in preadolescent In the first study, patients were randomized to receive doxycycline 100 mg once
children. Male and female subjects aged 9 to 11 years with an investigator’s global daily in combination with either A-BPO or vehicle for 12 weeks. Patients who had
assessment of 3 (moderate) and 20 to 100 total lesions were selected for study. at least a good improvement at the end of 12 weeks on either therapy were
Patients were randomized 1:1 to receive either A-BPO or vehicle for 12 weeks. eligible for a second study. Patients in the second study were randomized to
Treatment success was defined as achieving a score of clear or almost clear with at receive A-BPO or vehicle as maintenance therapy for 24 weeks (36 weeks of
least 2 grades of improvement from baseline. At the end of 12 weeks, 49.3% of the treatment). Patients completed the Acne-QoL at baseline, week 12, and week 36.
A-BPO group achieved success compared to 15.9% of those given vehicle (P \.001). QoL scores improved in both treatment groups from baseline to week 12 in all 4
Median percentage reduction in total lesion count was 68.6% in the A-BPO group domains (P \ .001). The QoL score in the A-BPO maintenance therapy group
and 19.3% in the vehicle group (P \ .001). The most common adverse events continued to improve at week 36 in all domains (P \ .001), except for acne-
occurring in [2% of patients given A-BPO were erythema, dry skin, skin discomfort, symptoms, which remained unchanged (P ¼ .127). Patients given vehicle saw
skin irritation, and skin burning sensation. No serious adverse events were reported. significant declines in QoL at week 36 (P \.025). This data indicates that patients
As shown here, A-BPO is an effective and well tolerated acne therapy in children with severe acne vulgaris and while acne symptoms remain stable, QoL in other
ages 9 to 11. areas continues to improve during maintenance therapy after cessation of oral
treatment.
Supported by Galderma Research and Development, SNC.
Supported by Galderma Laboratories, L.P.
AESTHETIC DERMATOLOGY
P6511
A comparison of the efficacy and safety of incobotulinum toxin A and
onabotulinum toxin A in subjects with periocular rhytides and masseteric
hypertrophy
Jae Hyung Lee, MD, Samsung Medical Center, Seoul, South Korea; Cho Rok Kim,
P6058 MD, Samsung Medical Center, Seoul, South Korea; Dong Youn Lee, MD, PhD,
Samsung Medical Center, Seoul, South Korea; Jong Hee Lee, MD, Samsung
Treatment of acne scars using a 1450-nm diode lasers Medical Center, Seoul, South Korea; Joo Heung Lee, MD, PhD, Samsung Medical
Tomohiko Narita, PhD, Kinki University Hospital, Faculty of Medicine, Osaka- Center, Seoul, South Korea; Mi Young Jung, MD, Samsung Medical Center, Seoul,
Sayama, Japan; Akira Kawada, Kinki University Hospital, Faculty of Medicine, South Korea
Osaka-Sayama, Japan; Ayaka Hirao, Kinki University Hospital, Faculty of
Medicine, Osaka-Sayama, Japan; Naoki Oiso, Kinki University Hospital, Faculty Incobotulinum toxin is a newly developed botulinum toxin A in which the
of Medicine, Osaka-Sayama, Japan; Ryoko Morita, Kinki University Hospital, complexing proteins had been removed. To compare efficacy and safety of
Faculty of Medicine, Osaka-Sayama, Japan incobotulinum toxin A, we designed randomized, double-blind, split-face study in
subjects with periocular rhytides and masseteric hypertrophy. Fifty-eight periocular
Background: Acne and acne scars affect individuals during puberty and adolescence, rhytides patients were treated with onabotulinumtoxin A and incobotulinum toxin
and inhibit their quality of life. The aim of this study was to evaluate the efficacy and A at each side of face. Other 56 patients were treated with onabotulinum toxin A and
tolerability of a 1450-nm diode laser on acne scars in Asian patients. incobotulinumtoxin A for the treatment of masseteric hypertrophy. Patients were
Methods: Twenty-five Japanese patients (17 female and 8 male, aged 15-44 years) assessed with a 10-point visual analogue scale (VAS) before treatment and all
with acne scars were treated with 10 sessions of the 1450-nm diode laser on 3- to posttreatment time points (1, 2, and 4 months for masseteric hypertrophy; 1 week,
4-week intervals. Clinical evaluation by physicians and photographs were conduct- 2, and 4 months for periocular rhytides) by investigators and subjects themselves.
ed at baseline, at 1 month after the final treatment, and at a 3-month follow-up visit. Patients were also photographed at each visit. In all these 2 comparison studies,
periocular rhytides and masseteric hypertrophy study, incobotulinum toxin A and
Results: All patients completed the study. Seventy-five percent of the subjects onabotulinum toxin A had statistically similar efficacy and safety. Onset time of
showed at least more than 30% improvement of acne scars. At the 3-month follow-up incobotulinum was also not inferior to onabotulinum in the both studies. No adverse
evaluation, 92.9% of the subjects with [30% improvement maintained the event was reported by any group with either side of the face at all posttreatment
effectiveness. Vesicle formation and transient hyperpigmentation also occurred in point. Although, these studies had small sample size and assessment tools were not
1 case. validated, Incobotulinum toxin A offers noninferior efficacy in the treatment of
Conclusion: The 1450-nm diode laser therapy was effective and well-tolerated in periobit rhytidies and masseteric hypertrophy compared with onabotulinum toxin
patients with acne scars, suggesting that this may be an appropriate modality for A. Additional studies are needed to compare the 2 products in different muscle
treating facial acne scars. groups and for other indications.