Efficacy assessments were performed at baseline, week 3,
and week 6 and included a standard visual scale, measurement
of thigh and upper-arm circumference, and a questionnaire.
The standard visual scale proposed by Bielfeldt
et al.9 was used to assess cellulite (Fig. 1). Three independent
investigators graded the severity of cellulite on
the posterior thighs from 0 to 9, with larger numbers indicating
more severe cellulite.
The most proximal site of the thighs and upper arms were
marked with dots using a gentian violet surgical pen.
Thigh and upper-arm circumference were measured at the
sites of the gentian violet pen marks. Subjects answered
questionnaires concerning the subjective improvement of
cellulite, degree of moisture, elasticity, general satisfaction
with the treatment, and the presence of skin irritation.
The degrees of moisture and elasticity were objectively measured
on the thigh and medial side of the upper arm by a
corneometer and cutometer, respectively, at every visit.
The corneometer measures the degree of moisture as very
dry (<35), dry (35∼50), or sufficiently moisturized (>50).
Cutometer values consist of R0 to R9 values. According to
the principle, higher R2 or R7 values indicate increased
skin elasticity and a lower R9 value indicates a decreased
skin-tiring effect.
Safety evaluation
Safety was assessed by inquiring about local irritation or
other adverse events through questionnaires.
Statistical analysis
Results including the visual grade of cellulite, thigh and
upper-arm circumference, and corneometer and cutometer
values were analyzed by the Friedman test. Null hypotheses
of no difference were rejected at p<0.05. Statistical
analysis was performed using IBM SPSS Statistics ver. 20.0
(IBM Co., Armonk, NY, USA).