| Objective: Androgenetic alopecia(AGA)is the most common hair problem in clinic.The pathogenesis of AGA is complicated and there is no effective therapy at present.With the rapid development of medical technology,some new transdermal transmission technologies have been used in the treatment of external drugs increasingly.However,the effective rate of minoxidil,a traditional drug,is only 40% to 60%.Therefore,some new treatments,such as growth factors,are also starting to be used to treat AGA,with good results.The purpose of this study is to evaluate the efficacy and safety of nano-microneedle combined with growth factor in the treatment of AGA by clinical observation and laboratory study,and to provide a new scheme for AGA.Methods: Forty male volunteers between the ages of 22 and 50 who were specifically diagnosed with AGA were recruited according to the inclusion criteria.Type of alopecia is classified by BASP method,all of them provided written informed consent.The subjects were randomly divided into four groups,ten volunteers in each group,received nano microneedle combined with saline,minoxidil alone,nano-microneedle combined with growh facor,nano-microneedle combined with growth facor and minoxidil external use.Nano-microneedle group received 16 sessions of treatment at a 1-week interval,external minoxidil group received four months of treatment twice a day.Follow up for three months after all treatment.All subjects were taken standard head photographs,oil content measurement,hair density and thickness test,patient and physician efficacy evaluaions,pain scores and adverse reactions to compare the efficacy and safety during and after treatment.In addition to nano-microneedle combined with saline,the other three groups were randomly selected three people from each group.Biopsies were taken from scalp at baseline and one week after the 16 th session.Before treatment,respectively,one scalp tissue was taken from alopecia and non-alopecia area.After teratment,one scalp tissue was taken from non-alopecia area.A total of three biopsies were performed on each subject.Some of the specimens were used to observe the changes of hair follicles with hematoxylin-eosin stainning.The other part was to detect the expression of nuclear transcription factor(GLi1)in Shh pathway by real-time quantitative PCR and to further explore the mechanism of growth factor promoting hair growth.Result: 1.Dermoscopy assessments: The hair density and hair follicle density of the other three groups were increased after treatment(p<.05),except that the nano-microneedle combined with saline group had no obvious change.The increase of hair thickness and the decrease of oil content were also observed in the group treated with minoxidil alone.In order to select the optimal treatment plan,we compared the treatment results of the remaining three groups,and found that the combination of nano-microneedle combined with growth facor and minoxidil external use was the best,better than the other two groups alone.But there was no significant difference between the other two groups.Furthermore,we compared the saline and growth factor combined with nano-microneedle group seperately,and found that the growth factor has the effect of promoting hair growth(p<.05).2.Subjective satisfaction evaluation: Two dermatologists who were not involved in the study evaluated the changes based on the photographs.The results showed that 70% of the subjects,except in the saline group,were better than before treatment.Using the self-administered questionnaire,90% of the subjects thought they had improved.However,either treatment has a poor effect on hair loss of forehead and U-type.3.Adverse effects: 0-10 represent different degrees of pain.In the instrument group,20% of the people thought it was painless,and 80% thought it had pain of 1-3 grades.None of the participants complained about erythema,edema,bleding,infection,eczema,scab after the treatment.However,there were six cases with increased head desquamation.4.Hematoxylin-Eosin Stainning: The results showed that after treatment,the number of hair follicles and the thickness of epidermis increased,and the tissue structure was more regular and compact.In addition,the hair follicles in the alopecia area are obviously miniaturized than the non-alopecia area.5.q-PCR: The expression level of Gli1 gene in Shh pathway showed that the expression of Gli1 m RNA in the non-alopecia was 2.2 times higher than that in the alopecia berore treatment(p<.05).However,there was no significant difference after treatment compared with before treatment in the alopecia area.Conclusion: 1.By comparing the hair density between the saline and growth factor combined with nano-microneedle,it is proved that the growth factor can promote hair growth.2.The combination of nano-microneedle with growth factor and minoxidil alone was better than that of one of them alone.3.Shh pathway involved in hair growth and may play a regulatory role.4.By observing the pain degree and adverse reactions of the four groups,it is proved that nano-microneedle assisted growth factor is safe and reliable in the treatment of AGA. |
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