Abstract
BackgroundDue to increasing interest from acne patients concerned about the side effects associated with conventional therapies, complementary and alternative medicine (CAM) has been suggested as a new therapeutic modality for acne vulgaris. Herbal medicine is one of these CAM treatments. Cheongsangbangpoong-tang (CBT) is a common herbal formula used in patients with acne vulgaris in the clinical practice of Korean Medicine (KM). However, despite the common use of CBT in clinical practice, the current level of evidence is insufficient to support an inhibitory effect of CBT on inflammatory acne lesions and facial heat. Therefore, this study was designed to assess the inhibitory effect of CBT on both inflammatory acne lesions and facial heat.Methods/designA randomized, double-blind, parallel-group, and placebo-controlled trial will be conducted. Fifty-six participants with acne vulgaris will be randomized into one of two groups: the CBT or placebo groups. After randomization, participants will be prescribed either CBT or placebo three times a day at a dose of 5 g after meals for 8 weeks. The following outcome measurements will be used in the examination of subjects: the mean percentage change and the count change of the inflammatory and non-inflammatory acne lesions, the temperature of facial points on digital infrared thermal imaging (DITI), serum cortisol, serum dehydroepiandrosterone-sulfate (DHEA-S), visual analogue scale (VAS), investigator global assessment (IGA), and severity score on the Korean Acne Grading System (KAGS) from baseline to the end of the trial.DiscussionThis trial will provide evidence regarding the inhibitory effect of CBT on inflammatory acne lesions and facial heat. The findings of this trial may have important implications for the more widespread use of CBT for the treatment of acne vulgaris.Trial registrationThe trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001468.
Highlights
Due to increasing interest from acne patients concerned about the side effects associated with conventional therapies, complementary and alternative medicine (CAM) has been suggested as a new therapeutic modality for acne vulgaris
This trial will provide evidence regarding the inhibitory effect of CBT on inflammatory acne lesions and facial heat
CBT is widely used for the treatment of acne in clinical practice, but the underlying mechanism has not yet been proven
Summary
Due to increasing interest from acne patients concerned about the side effects associated with conventional therapies, complementary and alternative medicine (CAM) has been suggested as a new therapeutic modality for acne vulgaris. Cheongsangbangpoong-tang (CBT) is a common herbal formula used in patients with acne vulgaris in the clinical practice of Korean Medicine (KM). Despite the common use of CBT in clinical practice, the current level of evidence is insufficient to support an inhibitory effect of CBT on inflammatory acne lesions and facial heat. This study was designed to assess the inhibitory effect of CBT on both inflammatory acne lesions and facial heat. CBT was first mentioned in ‘Wanbinghuichun’ as a novel herbal therapeutic formula. It cleans the upper energizer pathogenic heat, which is considered the major pathogenic cause of acne in Korean traditional medicine, and treats the sores and furuncles on the head and face [6]. Until now, no well-designed and randomized clinical trial supporting this classic substance has been performed
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