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IRCT20191013045092N3 IRCT 2022-09-18 Shiraz University of Medical Sciences Comparison of the therapeutic effect of intralesional injection of botulinum toxin with placebo in patients with androgenetic alopecia receiving finasteride tab Comparison of the therapeutic effect of intralesional injection of botulinum toxin with placebo in patients with androgenetic alopecia receiving finasteride tab 2022-07-25 anticipated 48 Complete https://irct.ir/trial/64814 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to one of two groups A and B based on block randomization. Medicines will be provided to the patient in an envelope based on the specified group. In one group, daily Finasteride 1 mg tablets manufactured by Soha Pharmaceutical Company will be prescribed, as well as 150 units of botulinum toxin type A Masport 500 units of Masoun Daro Company with 5 ml of diluted normal saline in 30 points on the patients' heads (for each point 5 units) is injected by insulin syringe. In the second group, the patients will be prescribed 1 mg finasteride tablets made by Saha Pharmaceutical Company daily, and instead of botulinum toxin, 1.5 ml of normal saline will be injected in 30 points of the patient's head with an insulin syringe, Blinding description: Finasteride tablets will be given to all patients, but the intralesional injectable drug (Botox or placebo) will be prepared by the design partner and will be specified in two envelopes A and B based on random groups and will be given to the clinical caregiver for injection. Therefore, neither the participant nor the clinical caregiver, the researcher and the outcome assessor will know about the type of substance injected. 3 male androgenetic alopecia. Intervention 1: In the intervention group, daily finasteride 1 mg tablets manufactured by Soha Pharmaceutical Company will be prescribed for patients, as well as 150 units of botulinum toxin type A Masport 500 units (Masoun Daru Company) with 5 ml of diluted normal saline in 30 places on the patients' head (for Each point 5 units) is injected with an insulin syringe. Intervention 2: Control group: In the control group, the patients will receive 1 mg finasteride tablets made by Soha Pharmaceutical Company daily, and instead of botulinum toxin, 1.5 ml of normal saline will be injected in 30 points of the patient's head with an insulin syringe. Yes - There is a plan to make this available What will be shared: article When: article publication time To whom: researchers Conditions: In order to raise the scientific level of researchers in this field through articles Where to obtain: executor of plan How to obtain: Submit request, review project manager and send feedback Comments:
public Dr. Ladan Dastgheib
Dermatology Department, floor 3, Shahid faghihi hospital,Karim khan zand street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3231 9049 dastgh@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Ladan Dastgheib
Dermatology Department, floor 3, Shahid faghihi hospital,Karim khan zand street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3231 9049 dastgh@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 1. Being male and older than 18 years 2. Suffering from androgenic alopecia grade 3 to 5 based on the Norwood Hamilton classification and Not receiving treatment for androgenic alopecia during the last 3 months 18 years no limit Male 1. Severe diseases of internal organs, eyes or skin 2. Diseases of the neuromuscular system 3. Inflammation, infection or unhealed wounds on the skin around the injection site on the head 4. Receiving systematic treatment with corticosteroids or other immunosuppressants and immune modulators in the last 3 months 5. Receiving anticoagulant and antiplatelet drugs 6. Hair transplantation in the past 7. Infectious underlying disease, autoimmune, malignancy 8. Phobia about treatment with botulinum toxin 9. Reluctance to continue Study participation during treatment and follow-up L64 Androgenic alopecia Treatment - Drugs Treatment - Drugs In the intervention group, daily finasteride 1 mg tablets manufactured by Soha Pharmaceutical Company will be prescribed for patients, as well as 150 units of botulinum toxin type A Masport 500 units (Masoun Daru Company) with 5 ml of diluted normal saline in 30 places on the patients' head (for Each point 5 units) is injected with an insulin syringe. Control group: In the control group, the patients will receive 1 mg finasteride tablets made by Soha Pharmaceutical Company daily, and instead of botulinum toxin, 1.5 ml of normal saline will be injected in 30 points of the patient's head with an insulin syringe. Hair density. Timepoint: Measurement of hair density at the beginning of the study and at the end of month 3 and at the end of month 6. Method of measurement: Photographing with a visioface 1000 D device. Shiraz University of Medical Sciences Approved 2022-07-16 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand St., Shiraz. Iran Shiraz Fars Iran (Islamic Republic of)