PIH and 20 percent had severe PIH. At week 4, 67 percent of
subjects had achieved at least a one-point improvement in IGA
scores (Table 6). At the conclusion of the trial (week 16), 100
percent of subjects had at least a 2-point improvement in IGA
scores. Of note, 31 percent of subjects had no PIH at all at week
16, 54 percent of subjects had only slight PIH at week 16 and 15
percent of subjects had just mild PIH at week 16. No patients
had moderate or severe PIH at week 16 (Table 7).
At week 4, there was a statistically significant 1-point median
improvement in distribution scores (P=0.0039). The majority
(60%) of subjects had at least a one-grade improvement in
distribution scores and 6.7 percent had at least a two-grade
improvement. At week 16, 100 percent of subjects had at least
a one-grade improvement and 92 percent of subjects had at
least a 2-grade improvement in distribution scores. Complete
clearance of PIH was noted in 31 percent of subjects at week
16; 54 percent of subjects had only 1-10 percent distribution of
PIH (Table 8).
Improvements in PIH severity and distribution were all
statistically significant starting at week 4.
Tolerability of AzA gel was good throughout the trial period,
with no serious adverse events reported. Erythema at baseline
was absent in 55 percent of subjects, trace in 30 percent and
mild in 15 percent. At week 4, 86.7 percent of subjects had no
erythema, 6.7 percent of the subjects had mild erythema and
6.7 percent had only trace erythema. By week 12, no subject
At week 4, 20 percent of the subjects reported trace dryness
and 6.7 percent had moderate dryness. Reported rates of
dryness remained low until week 16, at which point no subjects
reported dryness. Peeling, which was reported as trace in 6.7
percent of subjects and mild in 13.3 percent of subjects at week
4 was not reported by any subjects at week 12 or 16.
The development of PIH secondary to acne is a significant
clinical concern for many patients, especially those with darker
skin types. In our clinical practice, patients present every day
complaining of PIH, which they sometimes report is more
disturbing than acne itself. To be able to treat acne and PIH
simultaneously is a logical approach to care that may provide
enhanced convenience and better outcomes for patients. The
use of topical AzA gel 15% for the management of acne in
patients with PIH has been demonstrated to be well tolerated
and effective. Therefore, AzA gel may be considered for
patients at risk for this troubling sequelum of acne.
The limitation of this study is that it was an open-label study
with a small number of patients. However, positive findings of
this pilot study will hopefully encourage larger, randomized
controlled trials of AzA gel 15% for acne and post-inflammatory
hyperpigmentation, which is a significant unmet need.
Twice-daily topical application of AzA gel 15% improved all
aspects of acne severity and PIH severity measured during this
16-week study. This study revealed early onset of action in both
acne and PIH improvement starting at week 4.
In acne, improvement in total, inflammatory and non-inflammatory
lesion counts were seen throughout the study, with an
impressive 98 percent median reduction in total acne lesions
at week 16. IGA scores for acne showed statistically significant
improvement by week 4 that continued throughout the trial
period. Furthermore, both the severity and distribution of PIH
improved throughout the trial period. By the end of the study
period, nearly two-thirds of subjects had no PIH, and more than
half had only 1-10 percent involvement. AzA Gel 15% was also
well tolerated with minimal dryness and erythema. This open
label pilot study demonstrated that AzA Gel 15% is a safe and
effective treatment for PIH in skin of color patients with acne.
Dr. Leon H. Kircik has served as an investigator, speaker, consultant
or advisory board member for Allergan, Amgen, Astellas
Pharma US, Colbar, CollaGenex, Connetics Corporation, Ferndale
Laboratories, Galderma, Genentech, Intendis, Johnson
& Johnson, Leo Pharma, 3M, Nano Bio, Vovartis AG, Onset
Therapeutics, OrthoNeutrogena, Promius, PharmaDerm, Skin-
Medica, Stiefel, Valeant, Warner-Chilcott; a speaker for Abbott
Laboratories, Dermik, Embil, Innovail, Merck Serono and Triax;
an investigator for Acambis, Asubio, Bayer HealthCare, Biolife,
Biopelle, Breckinridge Pharma, Centocor, Combinatrix, Coria,
Dow Pharmaceutical Sciences, Dusa, GSK, Health Point, Medicis,
Nucryst, Obagi, QLT, Pfizer, QuatrixTolerRx and UCB; and as a
consultant for Laboratory Skin Care, Medical International Technologies
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