title: Assessing the Value of Botanical Anti-Inflammatory Agents in an OTC Acne Treatment Regimen.
abstract: BACKGROUND
  Over-the-counter acne treatments have assumed more importance for the dermatologist as access and affordability of prescription acne medications has decreased.
  
  
  OBJECTIVE
  This research evaluated the efficacy of a three step acne treatment regimen containing stabilized botanical anti-inflammatory ingredients as compared to a currently marketed acne regimen.
  
  
  METHODS
  80 female/male subjects 12+ years with mild to moderate acne (at least 10 inflammatory and 10 non-inflammatory lesions) were enrolled for 12 weeks and randomized to use the study botanical anti-inflammatory acne regimen or the traditional benzoyl peroxide comparator. Evaluations included investigator global assessment, investigator tolerability assessment, acne lesion characteristics (erythema, lesion height, diameter of inflammation, and amount of pus), subject product assessment, and digital photos at baseline, 2, 4, and 12 weeks.
  
  
  RESULTS
  The botanical regimen outperformed the comparator in terms of target lesion erythema, height, inflammation, and pus at weeks 2 and 4, perhaps due to anti-inflammatory ingredients, however parity was reached between the two products by week 12. No difference in lesion counts between the two groups was noted at week 2, however by week 4, there was a lower lesion count with the study regimen in terms of closed comedones (P<0.001) and inflammatory (P=0.016) lesions than the comparator. This statistically significant difference continued into week 12 with a reduction in closed comedones (P=0.006) for the study regimen.
  
  
  CONCLUSIONS
  Modern OTC cosmetic formulation ingredients including emollients, anti-inflammatory/antioxidants, and sensitive skin modulators provided an improved skin appearance, less lesional erythema, and a better overall appearance in subjects with acne treated for 12 weeks.
authors.forename: Zoe Diana
authors.initials: ZD
authors.lastname: Draelos
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D004890:Erythema / Q000188:drug therapy / Q000473:pathology; D005260:Female; D006801:Humans; D007641:Keratolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008517:Phytotherapy; D012867:Skin / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D007641:Keratolytic Agents; D001585:Benzoyl Peroxide