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

J Drugs Dermatol. 2012 Dec;11(12):1403-8.

Abstract

Background: A proprietary topical blend of salicylic acid and highly purified 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 efficacy 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 Evaluator'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 inflamed 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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Acne Vulgaris / pathology
  • Administration, Topical
  • Adolescent
  • Adult
  • Drug Combinations
  • Endpoint Determination
  • Erythema / chemically induced
  • Ethnic Groups
  • European Continental Ancestry Group
  • Female
  • Humans
  • Keratolytic Agents / administration & dosage
  • Keratolytic Agents / adverse effects
  • Keratolytic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Patient Compliance
  • Plant Oils / administration & dosage
  • Plant Oils / adverse effects
  • Plant Oils / therapeutic use*
  • Pruritus / chemically induced
  • Salicylic Acid / administration & dosage
  • Salicylic Acid / adverse effects
  • Salicylic Acid / therapeutic use*
  • Sesquiterpenes / administration & dosage
  • Sesquiterpenes / adverse effects
  • Sesquiterpenes / therapeutic use*
  • Sex Factors
  • Skin / pathology
  • Socioeconomic Factors
  • Young Adult

Substances

  • Drug Combinations
  • Keratolytic Agents
  • Plant Oils
  • Sesquiterpenes
  • Salicylic Acid
  • sandalwood oil