to VI were recruited for this trial. Inclusion criteria were: 15-60
inflammatory lesions with no more than 2 nodules and 20-100
non-inflammatory lesions and moderate-to-severe PIH.
At the baseline visit (week 0), patients were given AzA gel 15%
(Finacea, Intendis, Inc. Morristown, NJ) and were instructed to
apply the gel twice daily after facial cleansing. Patients returned
for four follow-up visits at weeks 4, 8, 12 and 16. Assessments at
each visit (baseline and each follow-up) included Investigator's
Global Assessment (IGA) of acne, assessed on a 6-point scale
(0=clear, 5=very severe) and total (papules, pustules, nodules,
open/closed comedones), inflammatory (papules, pustules
and nodules) and non-inflammatory lesion (open and closed
comedones) counts were also conducted.
IGA for PIH, assessed on a 7-point scale (0=clear, 6=very
severe, Table 1), was made at each visit. Distribution of PIH,
assessed on a 7-point scale (Table 2), was also assessed at each
visit. Tolerability, as indicated by the presence and degree of
peeling, erythema, dryness, oiliness, burning and pruritus, was
assessed at each follow-up visit.
A total of 20 adult subjects were enrolled. Mean age of subjects was 24 years. The majority of subjects (75%) were female; 25 percent were male. Eighty percent of subjects had Fitzpatrick skin type VI and 20 percent had Fitzpatrick skin type V (Table 3).
A total of 20 adult subjects were enrolled. Mean age of subjects was 24 years. The majority of subjects (75%) were female; 25 percent were male. Eighty percent of subjects had Fitzpatrick skin type VI and 20 percent had Fitzpatrick skin type V (Table 3).
RESULTS
Acne
At baseline, acne was rated by IGA as mild in 65 percent and
moderate in 35 percent of subjects.
At week 4, 47 percent of subjects had at least a one-point
improvement in IGA for acne (Table 4). Absolute mean
reduction in IGA at week 4 was statistically significant
(P=0.0156). Statistical significance continued throughout the
study (week 16, P=0.0005). At week 16, a significant proportion
of subjects (92%) had at least a one-point improvement in IGA
for acne. The percentage of subjects achieving at least a 2-point
improvement in their IGA for acne was 85 percent. Of note, at
week 16, 69 percent of all subjects were rated as clear based
on IGA.
There was a statistically significant reduction in total acne lesion
counts at week 4, at which time a 48 percent median reduction
in total lesion count was seen (P<0.0001, Table 5). Reduction in
total lesions remained statistically significant within the group
throughout the study period. At week 16, the mean reduction in
total lesions was 98 percent.
In terms of inflammatory lesions, specifically, the reduction in
inflammatory lesions was statistically significant throughout
the trial period, starting at week 4. Median reduction in lesion
