Li Lingyu,Zhu Le,Chen Mo,Zhao Ya,Zhou Ying,Yuan Dengfeng,Ni Xiangmei,Jia Haidong

Shanghai Jahwa United Co.,Ltd.,China

Abstract A natural whitening agent to replace synthetic bioactives was developed.Xin Qi Bai (XQB) was composed of traditional Chinese medicine (TCM) and the whitening efficacy was tested in vivo.Qualified volunteers were selected and used cream with or without XQB for 8 weeks continuously.The individual type angle (ITA°),melanin index (MI) and the stain area (%) were tested after 0,2,4 and 8 weeks.XQB can increase ITA° value,decrease MI value and the stain area of skin.Results showed that XQB has good whitening efficacy in vivo,and is a natural whitening agent.

Key words Whitening;in vivo;traditional Chinese medicine

Whitening agent is one of the most importantingredients in whitening cosmetics.Classical whitening agents,such as hydroquinone,kojic acid (KA) or mercury compounds may cause some harmful or damaging effects,and they are banned or limited in some markets[1,2].Natural whitening agents have increasingly received attention due to their good safety,few side effects and so on[3].

Chinese were fond of white skin a long time ago and left a lot of precious natural whitening prescriptions which were composed of TCM.“Qi BaiGao” was one of the most famous skin-whitening prescriptions and handed down from the Song Dynasty to the present day[4].It whitens the skin and removes blemishes by harmonizing the qi and blood.TCM is considered as a natural treasure and research on ancient TCM prescriptions holds great potential in the field of skin whitening[5].For more than 20 years,we have upgraded “Qi Bai Gao” to XQB through indepth research on its composition,process,ingredient and efficacy.In order to further verify the whitening efficacy of XQB,we have testedinvivo.

1 Materials and methods

1.1 Materials

XQB was provided by Shanghai Jahwa Biotechnology Co.,LTD (China).The composition of XQB (w/w) were Butylene Glycol 50%,Water 46.3%～48.6%,Ampelopsis japonica Root Extract 0.5%～1%,Paeonia lactiflora Root Extract 0.5～1%,Tribulus terrestris Fruit Extract 0.1%～0.5%,Bletilla striata Extract 0.1%～0.5%,Dictamnus dasycarpus Root Bark Extract 0.1%～0.5%,Poria cocos Sclerotium Extract 0.05%～0.1%,Atractylodes macrocephala Rhizome Extract 0.05%～0.1%.

1.2 Volunteers

Volunteers between the ages of 20 and 60 years(inclusive) were randomly divided into control group and sample group,35 volunteers in each group.The test was performed in accordance with Helsinki declaration.All volunteers signed informed consent.The volunteers should get though the skin noninvasive examination,without history of any skin or systemic diseases and without allergy to the test products.There is at least one obvious stain that the difference value of ITA° is greater than 10° from the surrounding skin and the diameter is not less than 3 mm (it cannot be freckles,pigmented moles,etc.,which are difficult to be improved by clinical use of topical preparations).

Because of the cosmetic nature of this study,the use of non-regulated test articles and/or monographingredients,and the low risk to volunteers (normal expectation),an institutional review board (IRB) was not used for review/approval of this clinical study.This decision conformed to the sponsor’s standard operating procedure on IRB review.

1.3 Test products

Sample 1 is cream with 1% w/w XQB,sample 2 is cream with 5% w/w XQB,control product is just cream.The cream does not contain any whitening agents and the composition is water,disodium EDTA,acrylates/C10-30 alkyl acrylate crosspolymer,hydroxyethylcellulose,hyaluronic acid,sodium hyaluronate,butylene glycol,hydroxyacetophenone,bis-PEG-18 methyl ether dimethyl silane,aroma,PEG-40 hydrogenated castor oil,PPG-26-buteth-26,phenoxyethanol,ethylhexylglycerin and tromethamine.

1.4 Test methods

The test took place from August to October,and volunteers were asked to maintain their original skin care habits during the test.All the test products were distributed according to test groups.During the test,the volunteers took an appropriate amount of the product,applied it to their faces evenly and gently until absorbed after cleansing the face in the morning and evening.The data were tested at the same time after 0,2,4 and 8 weeks.Before each test,the volunteers should wash and wipe their faces.After 30 minutes,test was started and the average value was taken after 3 consecutive tests.Skin color were tested by Konica Minolta Chromameter 2600d (Konica Minolta,Japan) and the output result is expressed by the chromaticity system (CIE,L*a*b*chromaticity system).ITA° was calculated by formula.The melanin content MI were tested with Mexameter MX 18 (CK,Germany).Standard images were taken with VISIA-CR skin analyzer (Canfiled,America) and Mirror Photo Tools (Canfiled,America) was used forimage analysis to get stain area (%).

1.5 Statistical analysis

All data were represented by mean ± SD and analyzed by paired t-test while compared before and after individual use,otherwise used the rank sum test while compared two related volunteers.Comparison between control group and sample group was performed by independent samples t-test or rank sum test.All statistical analyses were double-tailed.P<0.05 was considered as a statistically significant difference.

2 Results and discussion

There were 35 volunteers in the control group completed the study (one male participants and 34 female volunteers,average age is 49.03 ± 9.91 years).There were 34 volunteers in sample 1 group completed the study (two male participants and 30 female volunteers,average age is 42.94 ± 10.35 years).There were 32 volunteers in sample 2 group completed the study (34 female volunteers,average age is 49.06 ± 9.01 years).Reasons for dropping out from follow-up visits were given as holiday time,work and other family issues rather than any problem with the cream preparations.

In vivo study of whitening efficacy,ITA° value represents the skin brightness and is expressed by theL*a*b* color space system.The higher the value,the brighter the skin[6-8].The test results of ITA° value are shown in Table 1.During the test period,ITA° value of all the test groups gradually increased,which were time-dependent.It seems that all the test products have the effect of increasing ITA° value,regardless of whether there is XQB or not.After 8 weeks,ITA°value of sample 1 group increased by 11.02% while control group increased by 10.51%,and there was no statistical difference between the difference value of two groups.But ITA° value of sample 2 groupincreased by 27.42%,and compared with the control group,there was statistical difference between the difference value of two groups(#,P＜0.05).It shows that 1% w/w XQB failed to increase ITA°,5% w/w XQB increased ITA° greatly.It indicates that XQB has certain whitening efficacy(Table 1).

Table1.Changes in the ITA° value of the skin

MI value represents the melanin index.The lower the value,the lower the skin melanin content,the brighter the skin[9].The test results of MI value are shown in Table 2.During the test period,MI value of all the test groups gradually decreased,which were time-dependent.It seems that all the test products could decrease MI value,regardless of whether there is XQB or not.After 8 weeks,MI value of sample 1 group decreased by 9.84% while control group decreased by 8.48%,and there was no statistical difference between the difference value of two groups.But MI value of sample 2 group decreased by 11.83%,and compared with the control group,there was statistical difference between the difference value of two groups (#,P＜0.05).It shows that 1% w/w XQB failed to decrease MI,5% w/w XQB decreased MI greatly.It indicates that XQB has certain whitening efficacy (Table 2).

Table2.Changes in the MI value of the skin

Stain area (%) represents the size of the stain in the test area.The lower the value,the smaller the stain,the brighter the skin.The test results of Stain area (%) are shown in Table 3.Stain area (%) of all the test groups gradually decreased,which were time-dependent.It seems that all the test products could decrease stain area(%),regardless of whether there is XQB or not.After 8 weeks,stain area (%) of sample 1 group decreased by 8.96% while control group increased by 1.89%,and there was statistical difference between the difference value of two groups (#,P＜0.05).But stain area (%) of sample 2 group decreased by 14.22%,and compared with the control group,there was statistical difference between the difference value of two groups(#,P＜0.05).It shows that XQB decreased stain area (%) greatly and has certain whitening efficacy (Table 3).

Table3.Changes in the stain area (%) of the skin

It is worth mentioning that after the test,all the volunteers did not have any adverse skin reactions.According to the results,the cream without XQB can also increase ITA° value,decrease MI value and the stain area of skin,because it does not contain any whitening agents,but contains moisturizers such as hyaluronic acid.The moisturizers can increase the water content of the skin stratum corneum.The smooth,watery stratum corneum has regular reflections that make the skin bright and shiny[10].In this paper,statistical analysis was performed to compare the difference value of ITA°,MI and the stain area of skin between sample group and control group before and after use at the same time point.It eliminatesinterference from the baseline and blank cream.

3 Conclusions

In vivo whitening efficacy of XQB wasinvestigated in this study for the first time.It was found that XQB could increase ITA°,decrease MI value and the stain area of skin.All above indicated that XQB has good whitening efficacy,and is a natural whitening agent for the beauty industry.

In the 21stcentury,people still pay great attention to sustainable development issues.“Green cosmetics”are harmless to the environment and health for bodies,are the mainstream trend.11 China has a large quantity of TCM which is valuable natural resource.The research of TCM will contribute to the sustainable development of the world.Guided by the relatively complete theory of TCM and combined with the research of modern beauty mechanisms,various functional TCM additives were fully explored.It has important practical significance to promote the cosmetics industry in China and even the world.