Efficacy and Safety of Azelaic Acid (AzA) Gel 15% in the Treatment of Post-Inflammatory Hyperpigmentation and Acne: A 16-Week, Baseline-Controlled Study

June 2011 | Volume 10 | Issue 6 | Original Article | 586 | Copyright © June 2011

Leon H. Kircik, MD

table 1
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).



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