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IRCT20220901055844N1 IRCT 2023-12-19 Shiraz University of Medical Sciences A comparative study of the therapeutic effect of topical finasteride with oral finasteride in patients with androgenetic alopecia . A comparative study of the therapeutic effect of topical finasteride with oral finasteride in patients with androgenetic alopecia . 2024-01-10 anticipated 28 Complete https://irct.ir/trial/72075 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The design will be done in parallel (assignment of two groups). The randomization of the design will be done by the restricted randomization method, the permuted block randomization type will be used, and a random sequence will be created using the random allocation software. Replacement blocks of 4 are assigned to two treatments (groups A, b). So that at least 14 people are treated with oral finasteride and at least 14 people are treated with topical finasteride, Blinding description: Blinding will be done in such a way that two types of drugs will be provided to the patients by the second colleague of the resident of the project, and the collection of information before, three months after and 6 months after will be done by the resident of the project, who is not aware of the type of drug. Plan; The data with the name of the group will be provided to the consultant professor. 3 Androgenic alopecia. Intervention group: In group A, finasteride drug in oral form will be used. In this group, finasteride 1 mg tablets will be prescribed daily for male patients and 5 mg tablets manufactured by Ati Pharmed pharmaceutical company for female patients. In group B, the topical form of finasteride nano liposomal solution 0.1% will be used once a day. Finasteride nanoliposomes were prepared using the formulation prepared in the approved design and thesis of Dr. Mehyar Dari Gio under number 940768 at Mashhad University of Medical Sciences.will be. Then the properties of finasteride-containing nanoliposomes including particle size and zeta potential by DLS device.Morphology will be checked by electron microscope and stability on day 0, 1, 3, 6, 12 and 24 months at ambient temperature and 4 degrees, 25 and 37 degrees (according to ICH protocol.)which is sprayed on the surface of the area by the plastic applicator that comes with the product and massaged gently. Also, the patient will be warned not to wash the area for several hours after use, and to spray a little amount on the scalp and avoid a large amount. In order to use the same drug for the same patient on different days or for different patients, standard sprays were used, where every 12 to 15 puffs is equivalent to using 1 ml of the desired lotion.The duration of treatment in both groups is 6 months. And the visits of patients in both groups will be done at the beginning of the study and in the 3rd month and in the 6th month. Medicines are sent to the laboratory of Motahari Clinic in Shiraz for blood sampling, and the serum DHT levels will be checked for free before and after the start of treatment and after the end of 6 months of treatment. In order to comply with the blinding in the study, the resident is responsible for visiting and following up the response to the treatment in two groups and collecting information, they will not know the type of treatment given to the patients.. Yes - There is a plan to make this available What will be shared: The results of the study are shared When: The access period starts 6 months after the results are published To whom: The data of the study is made available to all people who are engaged in this industry Conditions: There are no conditions Where to obtain: via email Roya.Radanfar72@gmail.com How to obtain: From the time of sending the request by email for one month Comments:
public Mehdi Ghahartars
Shahid Faghihi Hospital, Zand Ave, Shiraz
Shiraz Iran (Islamic Republic of) 7134846114 +98 917 313 9214 Mehdighahartars@yahoo.com Shiraz University of Medical Sciences scientific Roya Radanfar
Shahid Faghihi Hospital, Zand Ave, Shiraz
Shiraz Iran (Islamic Republic of) 7134846114 +98 915 035 1139 Roya.Radanfar72@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Having androgenic alopecia grade 2 to 5 based on the Norwood Hamilton classification in men Age above 18 years Not receiving treatment for androgenic alopecia during the last 3 months Having androgenetic alopecia grade 2 to 3 according to Ludwig grading in women Menopausal women or women over 18 years of age who use IUD or TL. Informed consent to participate in the study 18 years no limit Both Failure to sign the consent form. History of allergic reaction and anaphylaxis to Finasteride drug Pregnancy or trying to have a child. Individual history of infertility Active infection or any scratches and wounds in the scalp L64 Androgenic alopecia Treatment - Drugs Intervention group: In group A, finasteride drug in oral form will be used. In this group, finasteride 1 mg tablets will be prescribed daily for male patients and 5 mg tablets manufactured by Ati Pharmed pharmaceutical company for female patients. In group B, the topical form of finasteride nano liposomal solution 0.1% will be used once a day. Finasteride nanoliposomes were prepared using the formulation prepared in the approved design and thesis of Dr. Mehyar Dari Gio under number 940768 at Mashhad University of Medical Sciences.will be. Then the properties of finasteride-containing nanoliposomes including particle size and zeta potential by DLS device.Morphology will be checked by electron microscope and stability on day 0, 1, 3, 6, 12 and 24 months at ambient temperature and 4 degrees, 25 and 37 degrees (according to ICH protocol.)which is sprayed on the surface of the area by the plastic applicator that comes with the product and massaged gently. Also, the patient will be warned not to wash the area for several hours after use, and to spray a little amount on the scalp and avoid a large amount. In order to use the same drug for the same patient on different days or for different patients, standard sprays were used, where every 12 to 15 puffs is equivalent to using 1 ml of the desired lotion.The duration of treatment in both groups is 6 months. And the visits of patients in both groups will be done at the beginning of the study and in the 3rd month and in the 6th month. Medicines are sent to the laboratory of Motahari Clinic in Shiraz for blood sampling, and the serum DHT levels will be checked for free before and after the start of treatment and after the end of 6 months of treatment. In order to comply with the blinding in the study, the resident is responsible for visiting and following up the response to the treatment in two groups and collecting information, they will not know the type of treatment given to the patients. The rate of improvement in hair growth. Timepoint: evaluating the improvement of hair loss at the beginning of the study and at the end of 3months and at the end of 6months. Method of measurement: Comparison of the effect of topical finasteride with oral finasteride in the treatment of androgenic hair loss. how to measure this variable is with a questionnaire. Serum Dihydrotestosterone. Timepoint: At the beginning of the study and at the end of 6 months. Method of measurement: by free blood sampling from the patient at the Motahari clinic in Shiraz byuse a lab kit to measure blood Dihydrotestosterone. Investigation of drug side effects. Timepoint: At the end of the 3rd month and the end of the 6th month. Method of measurement: At each stage, unwanted side effects, including redness, itching and symptoms of drug reaction, as well as breast tenderness, and symptoms of sexual dysfunction, are asked from the patients and recorded in the questionnaire. Shiraz University of Medical Sciences Approved 2023-04-15 Ethics committee of Shiraz University of Medical Sciences Shahid fagihi hospital, zand ave, Shiraz Shiraz Fars Iran (Islamic Republic of)