Irritant reaction on skin of long pepper extract in healthy volunteers (clinical trial phase I)
Keywords:
Irritant reaction, Ethanolic extract, Long pepper, Piper chaba, Healthy volunteers, การระคายเคืองต่อผิวหนัง, สารสกัดด้วยแอลกอฮอล์, ดีปลี, อาสาสมัครสุขภาพดีAbstract
Introduction: Testing promoter irritation and allergic reaction to the skin's immune is absolutely necessary for safety testing of the plant extract before formulation. Piper chaba fruits (long pepper) is a component in multi-drug formulations of Thai traditional medicine. It is used for topical pain relief, anti-inflammation of the muscles. In pharmacological studies, it could be used as anti-inflammatory and reducing pain. The extract is not toxic in either sub-acute and chronic toxicity test. Thus, study of safety of Piper chaba extract regarding irritation and immunomodulatory allergy on skin is necessary. These data are used for formulation of topical preparation in the future. Objective was to investigate on irritant reaction and immunomodulatory allergy of the ethanolic extract of Piper chaba fruit (long pepper) on skin in healthy volunteers.
Method: Clinical safety was studied of ethanolic extract of Piper chaba fruit (long pepper). The allergic reaction and irritation reaction in normal human skin were tested using closed patch test under occlusion by comparison between standard testing or TRUE test® as control with the concentration of the ethanolic extract of Piper chaba fruit at concentration 0.5, 1, 3 and 5%.
Result: From clinical study, ten healthy adults were 5 males, 5 females, aged and 21 - 56 years. They had no irritation or immunomodulatory allergic reaction with all the concentration of the ethanolic extract of Piper chaba fruit (long pepper) test and no irritation in TRUE test®. However, the irritation of positive allergic reagent, especially wool alcohol (lanolin), epoxy resin, thimerosal and gold sodium thiosulfate (GST) showed the highest frequency in these volunteers (frequency of finding in volunteer was 1/10 in each reagent or 10%).
Discussion and Conclusion: In conclusion, the ethanolic extract of Piper chaba fruit showed no irritation nor allergic reaction to human skin, so it may be safe and suitable for drug preparation and the other products of external skin treatment.
Key words: Irritant reaction, Ethanolic extract, Long pepper, Piper chaba, Healthy volunteers
