of the study. Clinical assessments at baseline and weeks 4, 8, and 12 included Investigator Global Assessment (IGA) of acne severity, inflammatory and non-inflammatory lesion counts, and clinical grading of skin health, including post-inflammatory hyperpigmentation/erythema (PIH/PIE). Bioinstrumentation (corneometer, tewameter, sebumeter) and subjective questionnaires on perception of efficacy were also completed at each visit.
Significant and progressive improvements were seen in acne parameters, shown in Table 2. Specifically, IGA of acne severity showed a decrease of 30% from baseline to week 12 (baseline: 2.47 ± 0.60, week 12: 1.73 +/- 0.71). In addition, IGA scores of acne severity improved in 85% of the participants by week 12. Average lesion counts also significantly decreased throughout the study, with a 35% decrease in inflammatory lesion counts and 47% decrease in non-inflammatory lesion counts (Table 2). Overall, clinical grading of skin quality parameters progressively and significantly improved throughout the study. Notably, post-inflammatory hyperpigmentation/ post-inflammatory erythema (PIH/PIE) parameters improved in nearly 80% of participants by week 12. Skin hydration as measured by the corneometer also improved in 74% of subjects. Sebumeter measurements improved significantly with a decrease of 25% as early as week 4 and remained lower than baseline throughout the study.
Participants also reported improvements at 12 weeks, including "clearer skin," "less breakouts," "less oily skin," and that their "acne had improved" (87%). Although preliminary, these results are promising and warrant further research. A randomized, placebo-controlled trial is currently underway.
CONCLUSION
Conventional treatments, while shown to be clinically effective in decreasing the severity of AV, are becoming more challenging to access with insurance companies often denying prescription medications for AV. In addition, side effects, including antibiotic resistance, photosensitivity, and pregnancy contraindications, are of concern to many patients considering oral therapies for AV. These barriers to treatment are a significant challenge for AV patients, leading many to search for alternatives that are safe and effective. Additionally, therapeutic options that reduce the need for topical and/or oral antibiotic therapy for AV are an important focus, as bacterial resistance to antibiotics is a clinically relevant concern both in the United States and globally.
Dermatologists are also recommending an increasing number of OTC treatment options as they are more easily accessible and affordable for patients. While effective, OTC treatments still target the conventional, local AV pathophysiology described as 4 major pillars at the site of the acne lesion. There is, however,
