Of all the skin changes possible after inflammatory
and nodulocystic acne eruptions of the
face, including postacne erythema, dyschromia, and
scarring, scarring leaves the most potentially permanent,
cosmetically and psychologically devastating
effects.1 Active acne, and probably facial acne
scarring, is associated with negative psychosocial
effects and poor quality of life.1 Acne scarring may
not resolve spontaneously, and procedural interventions
including surgery are required to reverse
these skin changes. Acne scarring can be classified
morphologically into atrophic or hypertrophic, or
more specifically boxcar or fixed, icepick, and
distensible or rolling scars.2–4 As expected given the
diversity of acne scarring morphology and severity,
certain treatment modalities are more effective
with certain subgroups of scarring.4 For example,
distensible scars are amenable to volumetric
correction with dermal fillers. Even with the
development of new treatment options, multiple
treatment modalities are likely to be required to treat
acne-scarred individuals.5,6
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The advent of dermal fillers began with bovine
collagen usage in the 1980s. In a small series, bovine
collagen was shown to have efficacy in the treatment
of acne scarring.7 Several studies have characterized
the effectiveness and longevity of different types of
permanent and semipermanent dermal fillers in the
treatment of acne scarring.8–10 Such fillers include
hyaluronic acid (HA)-based products with varying
degrees of cross-linking. These HA products have
themselves been shown to stimulate endogenous
collagen formation over time, which could contribute
to sustained volumetric correction of treated
scars,11 but the use of dermal fillers is not without
risk,12 and an awareness of existing treatment
algorithms is needed to manage potential complications.
13 Classically, device treatments such as
dermabrasion and laser resurfacing have been considered
first-line treatment of atrophic acne scarring.
2,14 Most recently, fractional carbon dioxide
(CO2) ablative laser was used successfully to treat
atrophic acne scarring in a small randomized controlled,
blinded evaluation.15 Subjects received three
treatments at 4- to 5-week intervals. The authors
concluded that acne scars can be safely improved
using ablative fractional CO2 laser resurfacing, with
improvement seen as soon as after 1 month and
sustained 6 months after treatment. They noted
that the use of higher energy levels might have
improved the results and possibly induced
significant adverse effects.15
The purpose of the study was to compare the safety
and efficacy profile of autologous fibroblast treatments
(LaViv, azficel-T, Fibrocell Sciences, Inc,
Exton, PA) of moderate to severe depressed,
distensible acne scars with that of vehicle
control treatments.
Materials and Methods
A centralized Institutional Review Board, Chesapeake
Research Review, Inc., reviewed and
approved the protocol and informed consent forms,
and written informed consent was obtained from all
99 subjects at seven U.S. sites before study participation.
The study was conducted in accordance
with Good Clinical Practices and principles that
have their origins in the Declaration of Helsinki.
Depressed, distensible facial acne scars (scars disappearing
completely with manual perilesional skin
stretching) were targeted for treatment in this study.
Evaluators were provided with a pictorial and
descriptive guideline outlining the acne scarring
morphology (depressed and distensible) considered
for autologous fibroblast treatment.16 Healthy subjects
with facial acne scarring on both cheeks were
enrolled in the study. To meet eligibility, subjects’
depressed distensible acne scars on both cheeks had
to be evaluator rated as moderate or severe on a
novel, validated 5-point acne scar assessment scale
(Table 1). Subject ratings of the appearance of each
cheek were required to be very dissatisfied or
dissatisfied (Table 2). Subjects were excluded if they
had hypertrophic acne scarring or numerous icepick
acne scars in the treatment area, had undergone
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