Safety assessment on comedogenicity of dermatological products containing d-alpha tocopheryl acetate in Asian subjects: A double-blind randomized controlled trial.

A double-blind randomized controlled trial was used to assess the comedogenic potential of the dermatological products containing d-Alpha tocopheryl acetate. A total of 15 healthy males (20-45 years old) with prominent follicular orifices and the ability to form comedones on the upper aspect of the back were enrolled. Each participant was given pads containing 4 test products. The positive control arm received a pad containing octyl palmitate which is a reported comedogenic material. The negative control arm received a pad without any test material. Participants were randomized to apply either the positive, negative or the active test cream to the application area for 4 weeks. Comedones were identified using epidermal biopsy under a stereomicroscope. The average number of microcomedone before exposure (baseline) with octyl palmitate was 6.1 ± 0.6 (mean ± SEM), and changed to 27.3 ± 4.7 which was more than 50% increase in comedone formation in every subject with the average change from base line was 365.4 ± 87.6%. In the negative control arm the average number of microcomedone at baseline was 6.4 ± 1.1 and at 4 week-application was 3.4 ± 0.6 (-43.0 ± 9.5% increased). All tested products produced less than a 50% increase in the number of microcomedones. Analyzed data from 12 subjects indicated non-comedogenic potential of the tested products containing-alpha tocopheryl acetate and other ingredients including lanolin, kernel oil and avocado oil and sunflower oil, etc. The octyl palmitate produced more than 50% increase in comedone formation in every analyzed subject.