Preadolescent Moderate Acne Vulgaris: A Randomized Trial of the Efficacy and Safety of Topical Adapalene-Benzoyl Peroxides
June 2013 | Volume 12 | Issue 6 | Original Article | 611 | Copyright © June 2013
Lawrence F. Eichenfield MD,a Zoe Draelos MD,b Anne W. Lucky MD,c Adelaide A. Hebert MD,d Jeffrey Sugarman MD,e Linda Stein Gold MD,f Diane Rudisill BS,g Hong Liu MS,g and Vasant Manna MDg
aRady Children's Hospital, San Diego, and University of California, San Diego, CA
bPrivate Practice, High Point, and Duke University School of Medicine, Durham, NC
cDepartment of Pediatrics, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
dDepartments of Dermatology and Pediatrics, University of Texas-Houston Medical School, Houston, TX
eUniversity of California, San Francisco, CA; fDepartment of Dermatology, Henry Ford Health Systems, Detroit, MI
gGalderma R&D, Cranbury, NJ
Abstract
OBJECTIVE: Evaluate the efficacy and safety of adapalene 0.1%-benzoyl peroxide 2.5% gel (adapalene-BPO) in patients 9-11 years old
with acne vulgaris.
METHODS: Enrolled subjects were male or female, with a score of 3 (moderate) on the Investigator’s Global Assessment (IGA) scale.
Subjects were randomized to receive adapalene-BPO or vehicle once daily for up to 12 weeks. Efficacy was evaluated by success rate
(percentage of subjects rated "clear" or "almost clear") at each visit, median percentage changes from baseline in total, inflammatory
and non-inflammatory lesion counts at each visit, the Children’s Dermatology Life Quality Index (C DLQI) at baseline and week 12, and
the Parent Assessment of Acne at week 12. Safety was assessed through evaluations of adverse events (AEs) and local tolerability
[erythema, scaling, dryness, and stinging/burning on scales ranging from 0 (none) to 3 (severe)].
RESULTS: A total of 142 subjects were randomized to adapalene-BPO and 143 to vehicle. At study endpoint (week 12), adapalene-BPO was
significantly superior to vehicle regarding treatment success (49.3% vs 15.9%, respectively), and regarding percentage reduction in total
lesion counts (68.6% vs 19.3%), inflammatory (63.2% vs 14.3%), and non-inflammatory lesion counts (70.7% vs 14.6%) (all P<.001).
More subjects using adapalene-BPO reported that their acne had no effect on their quality of life, and parents noted that their child’s acne
significantly improved. Adapalene-BPO was well tolerated, with mean tolerability scores less than 1 (mild).
CONCLUSIONS: In preadolescents with acne, adapalene-BPO leads to significantly superior treatment success and lesion count reduction
compared to vehicle.
J Drugs Dermatol. 2013;12(6):611-618.
INTRODUCTION
The epidemiology of acne vulgaris is evolving, with an
increasingly earlier onset seen in patients 8-11 years
old.1 Analysis of U.S. national data over approximately
the last thirty years indicates a significant decrease in the age
of children presenting for acne visits, with the greatest increase
in the early acne group.2 There is growing consensus about age
groupings in pediatric acne. Preadolescent acne without underlying
endocrinopathy is now considered by clinicians as a
normal variant, comprised of children 7-11 years old.3 Acne affects
all age groups, although peak incidence is at puberty due
to increased androgen production.4, 5 Acne in adolescents may
persist another 8-12 years, with about 7% continuing into the
third and fourth decade.6 Therefore, controlling acne early on
may help to minimize impact over the lifespan of disease. Furthermore,
an early onset of acne is associated with worsened
disease severity in later years, as demonstrated by a 5-year
cohort study of young girls who had early development of significant comedonal acne.7 In a prospective study of children
aged 5-12 years, sebum production and Propionibacterium acnes
(P. acnes) increased earlier in both prepubertal and pubertal
children who developed acne compared with children who did
not.8 Early onset of acne is also a risk factor for scarring, with
delayed treatment leading to worse scars.9
Treatment is always indicated when the clinician suspects current
or potential scarring or psychological morbidity, even in younger
patients with mild acne and few comedones.10 Pediatricians can
play a crucial role in the recognition and management of preadolescent
and adolescent acne. The use of a topical retinoid,
which targets the primary pathological lesion (microcomedone),
in combination therapy with benzoyl peroxide (BPO), a
broad-spectrum antimicrobial agent with no potential for inducing
bacterial resistance, has been recommended for treatment
of mild to moderate acne.11-12 A fixed-dose combination gel of
adapalene 0.1% and benzoyl peroxide (BPO) 2.5% (adapalene-
BPO) was demonstrated to be significantly more efficacious than
either adapalene or BPO alone in patients with moderate acne
vulgaris.13-15 Moreover, a synergy was demonstrated for the combination,
