Toxicity Study On Skin Administration Of Compound Melanterite Functional Shampoo And Clinical Observation On Its Effects In Treating Scalp Seborrheic Dermatitis

Objective: To investigate the safety of skin administration of compound melanterite functional shampoo via studying its toxicity of animal skin administration.The clinical effects of compound melanterite functional shampoo have been investigated during treating scalp seborrheic dermatitis through randomized and controlled experiment in order to provide scientific experimental proof for further development and research of compound melanterite functional shampoo.Methods: 1.Healthy white rabbits were given single-dose and multiple-dose skin irritation tests in order to observe their skin erythema and degree of edema and conduct rating by using a self-contrasted method and assess the stimulating intensity of compound melanterite functional shampoo.Healthy white rabbits were given skin allergic tests using Buehler Test(BT)and then divided into the positive group and negative control group.Guinea pig's local and systematic allergic reactions were investigated.The erythema and edema were graded to calculate the incidence of allergic reactions and evaluate the allergic response intensity.SPF SD rats were given skin acute toxicity tests and chronic toxicity tests and divided into high-concentration group,low-concentration group and blank control group.Acute toxicity test adopted the single dose to investigate the general state,weight and local and systematic responses of rats in intact skin group and damaged skin group.Chronic toxicity test introduced the successive doses for 90 days to investigate the general state and changes of weight and inspect the blood routine and all biochemical indexes before and after testing.Gross anatomy was carried out after testing so as to work out the visceral indexes;conduct the histopathological examination;and evaluate the chronic toxic reactions.2.A total of 104 patients meeting the standards of scalp SD were randomly divided into two groups,of which 52 patients received the external use of compound melanterite functional shampoo in the trial group while 52 patients received the external use of ketoconazole(KCZ)lotion in the control group,twice a week,4 weeks as a course of treatment to observe the pre-and post-treatment symptoms and signs and make a score;evaluate the drug therapeutic effects;and investigate the adverse drug reactions.Results: Toxicity tests: 1.Compound melanterite functional shampoo has no irritation on rabbit's intact skin regardless of single or multiple skin administration.It only has mild irritation to rabbit's newly damaged skin.But the erythema and edema won't be aggravated after successive administration.Those symptoms will disappear gradually within 72 hours after administration.2.Compound melanterite functional shampoo has no sensitization to guinea pig's intact skin.3.Compound melanterite functional shampoo won't affect rat's general state and weight in intact skin group and damaged skin group.No erythema and edema and so on local and systematic toxic responses have been found and no acute toxicity.4.Compound melanterite functional shampoo won't produce significant impacts on rat's general state,weight,blood routine and biochemical indexes,visceral indexes,histopathological examination.No local and systematic adverse reactions have been found and no chronic toxicity.Clinical observation: 1.Overall efficacy comparisons between two groups: The symptoms and signs have been improved in both groups.The effective rate in the trial group and control group is 91.8% and 81.3%,respectively.The difference has statistical significance(P<0.05).The recovery rate is 53.1% and 37.5%,respectively,without significant difference(P>0.05).2.Integral comparisons before and after treatment in each group: All the differences have statistical significance(P<0.05).3.Integral comparisons after treatment between both groups: The average score is 2.16±2.97 in the trial group and 5.13±5.60 in the control group.The difference has statistical significance(P<0.05).4.Different parting ratio in the trial group: 29 cases of wet type and 20 cases of dry type,the effective rate is 96.6% and 85.0%,respectively,without significant difference(P>0.05).The recovery rate is 58.6% and 45.0%,respectively,without significant difference(P>0.05).5.Recurrent rate comparisons 4 weeks after drug withdrawal: The recurrent rate is 15.6% and 35.9%,respectively in the trial group and control group.The difference has statistical significance(P<0.05).6.No adverse allergic reactions are reported during the trial.Conclusion: 1.Compound Melanterite Functional Shampoo has good safety by dermal administration.It only has mild irritation to a fresh damaged wound on the skin of rabbits.Therefore,it should be used with caution if there is a fresh wound on the scalp.2.The therpeutic effect of Compound Melanterite Functional Shampoo is confirmed,safe and convenient in treating scalp SD.Therefore,it can be used for various types of scalp SD.Patients usually have a high acceptance.It can reduce the recurrence rate and worthy of further R&D and promotion.