Single-Center, Open-Label Study of a Proprietary Topical 0.5% Salicylic Acid-Based Treatment Regimen Containing Sandalwood Oil in Adolescents and Adults With Mild to Moderate Acne

December 2012 | Volume 11 | Issue 12 | Original Article | 1403 | Copyright © December 2012


Ronald L. Moy MD,a Corey Levenson PhD, b Jeffrey J.So MS PA-C,a and James A. Rock MS c

aMoy-Fincher Facial Plastics/Dermatology, Beverly Hills, CA bSantalis Pharmaceuticals, San Antonio, TX cTKL Research, Rochelle Park, NJ

Abstract
Background: A proprietary topical blend of salicylic acid and highly puri!ed sandalwood oil from Australia was used in this open-label study in adolescents and adults with mild to moderate facial acne.
Methods: The investigational regimen consisted of a foaming cleanser, an acne serum, a spot treatment, and a mask. Patients applied the treatment regimen as directed for 8 weeks. The primary ef!cacy measure was the percentage of patients assessed as improved, much improved, or very much improved according to the Global Aesthetic Improvement Scale (GAIS) ratings at week 8. Severity was rated using the Evaluato's Global Severity Scores (EGSS) at baseline and weeks 2, 4, and 8. Tolerability was assessed at baseline and weeks 2, 4, and 8 by asking patients to rate the severity of itching, scaling, erythema, burning, dryness, and stinging. Patients were also asked to complete an acne questionnaire.
Results: 89.4% (42/47) met the primary end point determined by the GAIS of improved (66%), much improved (19%), or very much improved (4%). Notable reductions in lesion counts were observed in patients with more severe or in"amed lesions. Tolerability was queried at all visits. No itching, scaling, or erythema was reported after initial application. Symptoms of intolerability peaked at week 2; however, most events were mild to moderate and were typically reported with use of the mask component. Intolerance decreased by week 4 and by week 8. The treatment regimen was well tolerated by patients.
Conclusions: Results from this study support the use of a proprietary investigational regimen in patients with mild to moderate acne and warrant further investigation to determine whether longer-term therapy (ie, beyond 8 weeks) results in enhanced efficacy with minimal side effects, leading to continued patient compliance and skin improvement.

J Drugs Dermatol. 2012;11(12):1403-1408.

INTRODUCTION

Current therapies for acne include topical treatments, systemic antibiotics, hormonal agents, isotretinoin, complementary therapies, and other miscellaneous treatments.1 Excluding benzoyl peroxide preparations, regimens containing salicylic acid (SA) as the active ingredient are the most widely used. Salicylic acid is thought to work by penetrating into comedones and has mild anti-inflammatory properties and keratolytic effects, leading to desquamation of the epidermis and dermal matrix regeneration.2 Salicylic acid can optimize the texture and tone of treated skin.3,4
Because of the high side-effect profile of benzoyl peroxide and resultant poor patient compliance, there is an increased need for efficacious and tolerable acne products without benzoyl peroxide. Over-the-counter (OTC) products containing SA are readily available, but clinical evidence supporting their use is limited. Effective products must have acceptable safety and tolerability profiles to support long-term usage. In addition to the active ingredient(s), other components of any treatment regimen are used to improve long-term usage and product acceptability.
The investigational regimen used in this study included 0.5% SA plus up to 2.0% highly purified sandalwood oil from Australia, a well-characterized botanical product with documented antibacterial, anti-inflammatory, and restorative properties.5,6 Sandalwood oil has been shown to be an effective antibacterial against Staphylococcus aureus, Staphylococcus epidermidis, and Propionibacterium acnes at concentrations of 0.06% and lower6 (Santalis, unpublished data) and to exert anti-inflammatory effects mediated by inhibition of cyclooxygenase(COX)-1, COX-2, and 12-lipoxygenase pathways6 and in lipopolysaccharide-stimulated dermal fibroblast and keratinocyte models through the downregulation of proinflammatory cytokines and chemokines, including interleukin (IL)-6, IL-8, epithelial neutrophil-activating peptide-78, macrophage inflammatory protein 1α., granulocyte colony-stimulating factor, and granulocyte macrophage colony-stimulating factor (Santalis, unpublished data).6 In traditional medicine, sandalwood oil was used to treat in!ammatory and eruptive skin diseases.7,8
Although many acne treatments are somewhat effective, none is 100% curative. Treatments that have undergone extensive clini-