This prospective, open-label, interventional study enrolled 20 subjects with PPR. Individuals aged 18 years or older with mild to moderate facial rosacea (as classified by Investigator Global Assessment [IGA]) and who had between 2 and 50 inflammatory facial lesions (papules or pustules) were eligible for participation. Patients with moderate or severe rhinophyma, ocular rosacea requiring topical or systemic antibiotics, or a history of hypersensitivity to any component of the gel were excluded. To prevent any carry-over effects of other medications, patients underwent an adequate washout according to drug type. Concomitant use of any treatments with effects in rosacea was prohibited for the duration of the study.
Subjects were instructed to apply azelaic acid 15% gel (Finacea Gel®) topically to the face twice daily for 12 weeks. They were also advised to avoid known rosacea triggers as much as possible. Clinical evaluations were made at baseline, weeks 4 and 12, and at 4 weeks after completion of active treatment (week 16). Effectiveness endpoints included inflammatory lesion counts, the IGA of rosacea severity, and participant's subjective evaluation of rosacea improvement. Adverse events were also monitored.
Treatment with azelaic acid 15% gel was associated with a statistically significant reduction in all lesions types, and the reduction in lesions persisted beyond the treatment period. There was a significant decrease in mean total inflammatory lesion count at all study visits compared to baseline. The greatest decrease was observed at week 12, the conclusion of active treatment, with a difference of -3.4 from baseline (P<0.05). The difference in mean lesion count between week 16 and baseline was -2.4. This reduction in lesions 4 weeks after treatment discontinuation remained significant relative to baseline (P<0.05) (Figure 1).
Most subjects perceived a change in their facial skin over the course of azelaic acid treatment. At week 12, 47% of patients self-reported a moderate to significant improvement while 31% reported a mild improvement (Figure 2).
At the baseline visit, the IGA of rosacea was documented as "moderate" or "mild" for the majority of patients. IGA scores improved at each visit, with all visits showing a significant improvement when compared to the IGA at baseline (P<0.05). By week 16, the majority of IGA scores had become ratings of "almost clear" or "mild" (Figure 3).
Overall, azelaic acid 15% gel was safe and well-tolerated. Adverse events were limited to mild itching and stinging that did not require a disruption of treatment or any additional intervention. No subjects discontinued participation in the study for any reason.
Mean inflammatory lesion counts at baseline (v2), week 4 (v3), week 12 (v4), and week 16 (v5).
Skin Therapy Letter. 2017;22(6):5-7. © 2017 SkinCareGuide.com