Summary
Background
Topical retinoids, such as adapalene, are an integral part of acne therapy in most
regions and are considered appropriate first-line therapy by international guidelines
for all cases of acne with the exception of the most severe. However, there are currently
no topical retinoids available for the treatment of acne vulgaris in Japan.
Objective
To confirm efficacy and safety of adapalene gel 0.1% versus the corresponding gel
vehicle in the treatment of Japanese patients with acne vulgaris for up to 12 weeks.
Methods
A total of 200 patients were randomized to receive adapalene gel 0.1%, or vehicle
once-daily for 12 weeks. Percent reduction in lesion counts (total, inflammatory,
and non-inflammatory) and subject satisfaction were evaluated. Safety was monitored
through adverse events and laboratory tests.
Results
Adapalene gel 0.1% produced significantly better reductions in total (P < 0.0001), inflammatory (P = 0.0010), and non-inflammatory lesions (P < 0.0001) at endpoint (week 12, last observation carried forward) than gel vehicle,
with a higher overall subject satisfaction. The primary efficacy variable, the median
percent reduction of total lesion counts at endpoint, was significantly greater with
adapalene gel 0.1% (63.2%) compared to that with the vehicle (36.9%) in the ITT population
(P < 0.0001). Significantly greater results were observed as early as week 1. Adapalene
was well tolerated, with adverse events that were mostly mild-to-moderate and transient
in nature.
Conclusions
Adapalene gel 0.1% was effective in the treatment of acne vulgaris in Japanese patients.
Adapalene was safe and well tolerated, consistent with the good tolerability profile
demonstrated in other patient populations.
Keywords
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Article info
Publication history
Published online: July 12, 2010
Accepted:
September 27,
2007
Received in revised form:
September 26,
2007
Received:
July 30,
2007
Identification
Copyright
© 2007 Japanese Society for Investigative Dermatology. Published by Elsevier Inc. All rights reserved.
