Isopropyl Myristate and Cocoa Butter are not Appropriate Positive Controls for Comedogenicity Assay in Asian Subjects

Lee, Eunyoung; Kim, Nahee

doi:10.4172/2471-9323.1000102

Cited by 1 publication

(5 citation statements)

References 18 publications

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“…In the present study, the conducted methodology was adopted from the previous studies [ 3 , 4 ], which tested on the upper aspect of the back. It was recommended that the test site should be related to the characteristics of the finished products due to the low correlation in comedogenic response of different areas [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

“…Generally, acetylated lanolin and isopropyl myristate (IPM) has been mainly used as a positive control in animal [ 10 ] and human models [ 3 ]. However, it has been suggested that IPM may not be a good positive control for comedogenicity test in human studies, particularly in Asian subjects having lower comedogenicity sensitivity than Caucasians [ 4 ].…”

Section: Discussionmentioning

confidence: 99%

“…Focusing on individual ingredient in the formulations, all ingredients used have been classified as being of non or weak comedogenic potential, according to study in animal or human model [ [2] , [3] , [4] ]. Moreover, they have provided various beneficial effects to the skin.…”

Section: Discussionmentioning

confidence: 99%

“…Each enrolled subject was given pads containing the tested products to apply to the upper aspect of the back. The positive control was the pad containing octyl palmitate which has been reported as a comedogenic material [ 3 , 4 ]. The negative control was a pad without any material.…”

Section: Methodsmentioning

confidence: 99%

“…In the present study, the comedogenicity of the marketed dermatological products were assessed by using human model modified from the previous study [ 3 , 4 ]. All tested products contained d-Alpha tocopheryl acetate in an amount 5 IU/100 g of product, as a main active ingredient.…”

Section: Introductionmentioning

confidence: 99%

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

Waranuch

Wisutthathum

Tuanthai

et al. 2021

Contemporary Clinical Trials Communications

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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.

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Section: Discussionmentioning

confidence: 99%