Rapid Treatment of Mild Acne With a Novel Skin Care System Containing 1% Salicylic Acid, 10% Buffered Glycolic Acid, and Botanical Ingredients
June 2014 | Volume 13 | Issue 6 | Original Article | 678 | Copyright © June 2014
Ashish C. Bhatia MDa,b and Felipe Jimenez PhDc
aDepartment of Dermatology, Northwestern University, Feinberg School of Medicine, Chicago, IL
bThe Dermatology Institute, Naperville, DuPage Medical Group, Naperville, IL
cEnvy Medical, Inc., Westlake Village, CA
The biggest hurdle in the treatment of acne vulgaris is patient non-compliance that is due in large part to poor tolerability to common acne medications. As such, new acne treatments must be developed that balance good anti-acne efficacy with excellent tolerability in order to ensure patient adherence and by extension ensure good clinical outcomes. The goal of the present study was to determine the tolerability and efficacy of a novel skin care system, composed of a cleanser, containing 1% salicylic acid and botanical ingredients, and a treatment gel, containing 1% salicylic acid, 10% buffered glycolic acid and botanical ingredients for the treatment of mild acne. In this single-center, open-label clinical study, 25 male and female volunteers used the test cleanser and test gel twice daily over six weeks. Tolerability assessments showed that the skin care regimen was very well tolerated by all study volunteers. Acne severity was significantly reduced by two acne grades at six weeks. Inflammatory lesion counts were significantly reduced, on average, by 59.06% (P
≤ 0.0001), 91.62% (P
≤ 0.0001), 90.85% (P
≤ 0.0001) and by 98.55% (P
≤ 0.0001) at weeks 1, 2, 4, and 6, respectively. Non-inflammatory lesion counts were reduced, on average, by 13.54% (ns), 38.95% (P
≤ 0.0001), 44.48% (P
≤ 0.0001), and by 56.10% (P≤ 0.0001) at weeks 1, 2, 4, and 6, respectively. Standardized photography also demonstrated a progressive reduction in acne lesions over time. In conclusion, results of the present study suggest that the tested skin care regimen offers rapid acne clearance and excellent tolerability that together may help to improve patient adherence as well as treatment outcome. J Drugs Dermatol.
Acne vulgaris is a multifactorial skin disorder affecting the pilosebaceous unit. The main factors involved in its pathogenesis include follicular hyperkeratinization, sebum overproduction, Propionibacterium acnes (P. acnes) over proliferation, inflammation and fluctuation in androgen levels.1 In addition, recent developments suggest that P. acnes bacteria interaction with Toll-like receptors (TLRs) may also play a role.2 It is estimated that acne vulgaris affects about 40 to 50 million individuals annually in the US alone, with an estimated annual cost of $2.5 billion.3 Of these affected individuals, roughly 85% are young people between the ages of 12 and 24 and 12% are women and 3% are men between the ages of 25 and 44.3 While acne vulgaris affects people of all races, Perkins and co-workers reported that it was more prevalent in African Americans and Hispanics in their evaluation of 2,895 women between the ages of 10 and 72 in four US cities.4
Common topical treatments for acne vulgaris include benzoyl peroxide (and benzoyl peroxide/antibiotic combinations), antibiotics (clindamycin, erythromycin and sodium sulfacetamide/sulfur) retinoids, salicylic acid and azelaic acid.5 Common oral medications may include minocycline, erythromycin, tetracycline, doxycycline, oral contraceptives, oral spironolactone, and isotretinoin.5 Although all of the aforementioned treatments can be used to effectively treat acne, they are not without either systemic or cutaneous side effects. For example, it is well known that chronic use of antibiotics to treat acne may lead to the development of antibiotic-resistant P. acnes bacteria.6 Using oral isotretinoin can cause systemic side effects including elevated liver enzymes, muscle pain, headaches, and dry skin.7 Cutaneous side effects of topical medications may include irritation, dryness, erythema, pruritus, and scaling in skin that can lead to the patient becoming non-compliant with the prescribed acne treatment regimen.8 In fact, poor medication adherence is one of the major reasons for treatment failure among patients with acne vulgaris.9 As such, new acne treatments must be explored that can afford a better tolerability profile while providing excellent efficacy in order to improve treatment adherence for the optimal treatment of acne vulgaris. The aim of this study was to determine the tolerability and efficacy of a novel skin care system, containing 1% salicylic acid, 10% buffered glycolic acid and botanical ingredients, for the treatment of mild acne vulgaris over 6 weeks in 25 males and females between the ages of 12 and 34.