P6243
Treatment of acne in children aged 9 to 11 with a fixed dose combination
of adapalene-benzoyl peroxide gel
Lawrence Eichenfield, MD, Rady Children’s Hospital San Diego, San Diego, CA,
United States; Adelaide A. Hebert, MD, Departments of Dermatology and
Pediatrics, University of Texas-Houston Medical School, Houston, TX, United
States; Anne W. Lucky, MD, Department of Pediatrics, Cincinnati Children’s
Hospital Medical Center, Cincinnati, OH, United States; Diane Rudisill, Galderma
Research and Development, Cranbury, NJ, United States; Jeffrey Sugarman, MD,
University of California, Santa Rosa, CA, United States; Linda Stein Gold, MD,
Department of Dermatology, Henry Ford Health Systems, West Bloomfield, MI,
United States; Zoe Draelos, MD, Dermatology Consulting Services, High Point,
NC, United States
Acne vulgaris is commonly observed in preadolescent children. However, most
topical therapies are indicated for patients aged 12 and older. A multicenter,
randomized, vehicle-controlled, double-blind study investigated a combination dose
of adapalene-benzoyl peroxide 0.1%/2.5% (A-BPO) to treat acne in preadolescent
children. Male and female subjects aged 9 to 11 years with an investigator’s global
assessment of 3 (moderate) and 20 to 100 total lesions were selected for study.
Patients were randomized 1:1 to receive either A-BPO or vehicle for 12 weeks.
Treatment success was defined as achieving a score of clear or almost clear with at
least 2 grades of improvement from baseline. At the end of 12 weeks, 49.3% of the
A-BPO group achieved success compared to 15.9% of those given vehicle (P \.001).
Median percentage reduction in total lesion count was 68.6% in the A-BPO group
and 19.3% in the vehicle group (P \ .001). The most common adverse events
occurring in [2% of patients given A-BPO were erythema, dry skin, skin discomfort,
skin irritation, and skin burning sensation. No serious adverse events were reported.
As shown here, A-BPO is an effective and well tolerated acne therapy in children
ages 9 to 11.
Supported by Galderma Research and Development, SNC.
P6058
Treatment of acne scars using a 1450-nm diode lasers
Tomohiko Narita, PhD, Kinki University Hospital, Faculty of Medicine, Osaka-
Sayama, Japan; Akira Kawada, Kinki University Hospital, Faculty of Medicine,
Osaka-Sayama, Japan; Ayaka Hirao, Kinki University Hospital, Faculty of
Medicine, Osaka-Sayama, Japan; Naoki Oiso, Kinki University Hospital, Faculty
of Medicine, Osaka-Sayama, Japan; Ryoko Morita, Kinki University Hospital,
Faculty of Medicine, Osaka-Sayama, Japan
Background: Acne and acne scars affect individuals during puberty and adolescence,
and inhibit their quality of life. The aim of this study was to evaluate the efficacy and
tolerability of a 1450-nm diode laser on acne scars in Asian patients.
Methods: Twenty-five Japanese patients (17 female and 8 male, aged 15-44 years)
with acne scars were treated with 10 sessions of the 1450-nm diode laser on 3- to
4-week intervals. Clinical evaluation by physicians and photographs were conduct-
ed at baseline, at 1 month after the final treatment, and at a 3-month follow-up visit.
Results: All patients completed the study. Seventy-five percent of the subjects
showed at least more than 30% improvement of acne scars. At the 3-month follow-up
evaluation, 92.9% of the subjects with [30% improvement maintained the
effectiveness. Vesicle formation and transient hyperpigmentation also occurred in
1 case.
Conclusion: The 1450-nm diode laser therapy was effective and well-tolerated in
patients with acne scars, suggesting that this may be an appropriate modality for
treating facial acne scars.
Commercial support: None identified.
APRIL 2013
P6457
Treatment with adapalene-benzoyl peroxide improve quality of life in
patients with severe acne vulgaris
Robert T. Brodell, MD, Northeastern Ohio Medical University, Rootstown, OH,
United States; Albert Wertheimer, PhD, Temple University, Temple University, PA,
United States; Darryl Toth, MD, XLR8 Medical Research, Inc, Windsor, Canada;
Delphine Bucher, Galderma International, La Defense, France; Elyse Rafal, MD,
Derm Research Center of New York, Inc, Stony Brook, NY, United States; Nabil
Kerrouche, MMSc, Galderma Research and Development, Biot, France; Stephen
Tyring, MD, Center for Clinical studies, Webster, TX, United States
Acne vulgaris is a common skin disease that can severely affect quality of life
(QoL). Patients often have depressive symptoms, low self-esteem, and poor body
image. The Acne-QoL questionnaire is a validated instrument that describes 4
domains of QoL: self-perception, role-emotional, role-social, and acne symptoms.
Two related clinical trials investigated the use of a combination dose of
adapalene-benzoyl peroxide 0.1%/2.5% (A-BPO) in the treatment of acne vulgaris.
In the first study, patients were randomized to receive doxycycline 100 mg once
daily in combination with either A-BPO or vehicle for 12 weeks. Patients who had
at least a good improvement at the end of 12 weeks on either therapy were
eligible for a second study. Patients in the second study were randomized to
receive A-BPO or vehicle as maintenance therapy for 24 weeks (36 weeks of
treatment). Patients completed the Acne-QoL at baseline, week 12, and week 36.
QoL scores improved in both treatment groups from baseline to week 12 in all 4
domains (P \ .001). The QoL score in the A-BPO maintenance therapy group
continued to improve at week 36 in all domains (P \ .001), except for acne-
symptoms, which remained unchanged (P ¼ .127). Patients given vehicle saw
significant declines in QoL at week 36 (P \.025). This data indicates that patients
with severe acne vulgaris and while acne symptoms remain stable, QoL in other
areas continues to improve during maintenance therapy after cessation of oral
treatment.
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,
MD, Samsung Medical Center, Seoul, South Korea; Dong Youn Lee, MD, PhD,
Samsung Medical Center, Seoul, South Korea; Jong Hee Lee, MD, Samsung
Medical Center, Seoul, South Korea; Joo Heung Lee, MD, PhD, Samsung Medical
Center, Seoul, South Korea; Mi Young Jung, MD, Samsung Medical Center, Seoul,
South Korea
Incobotulinum toxin is a newly developed botulinum toxin A in which the
complexing proteins had been removed. To compare efficacy and safety of
incobotulinum toxin A, we designed randomized, double-blind, split-face study in
subjects with periocular rhytides and masseteric hypertrophy. Fifty-eight periocular
rhytides patients were treated with onabotulinumtoxin A and incobotulinum toxin
A at each side of face. Other 56 patients were treated with onabotulinum toxin A and
incobotulinumtoxin A for the treatment of masseteric hypertrophy. Patients were
assessed with a 10-point visual analogue scale (VAS) before treatment and all
posttreatment time points (1, 2, and 4 months for masseteric hypertrophy; 1 week,
2, and 4 months for periocular rhytides) by investigators and subjects themselves.
Patients were also photographed at each visit. In all these 2 comparison studies,
periocular rhytides and masseteric hypertrophy study, incobotulinum toxin A and
onabotulinum toxin A had statistically similar efficacy and safety. Onset time of
incobotulinum was also not inferior to onabotulinum in the both studies. No adverse
event was reported by any group with either side of the face at all posttreatment
point. Although, these studies had small sample size and assessment tools were not
validated, Incobotulinum toxin A offers noninferior efficacy in the treatment of
periobit rhytidies and masseteric hypertrophy compared with onabotulinum toxin
A. Additional studies are needed to compare the 2 products in different muscle
groups and for other indications.
Commercial support: None identified.
J AM ACAD DERMATOL AB19