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IRCT20190210042676N10 IRCT 2020-07-19 Pars Behruzan Jam Company Evaluation of the effectiveness of biotin and dexpanthenol ampoules produced by Pars Behruzan Jam company in reducing hair loss Evaluation of the effectiveness of biotin and dexpanthenol ampoules produced by Pars Behruzan Jam company in comparison with reference drugs (produced by Bayer German company) in reducing diffuse and scattered hair loss 2020-07-22 anticipated 50 Complete https://irct.ir/trial/49278 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: An online site (https://www.sealedenvelope.com) will be used to generate a randomized list of study groups. According to the random block method and considering the four blocks, 12 blocks will be produced for 50 patients, Blinding description: The clinicians who performed the clinical assessments and objective device analysis are completely blinded to the treatment type. participants will receive the treatment according to the randomization list by an independent assistant. 2 hair loss. Intervention 1: Intervention group: Injection of 6 ampoules of Dexpanthenol 250 mg / 2 ml, produced by Pars Behruzan Jam Company, as a muscle injection, within 6 weeks+Injection of 6 ampoules of Biotin 5 mg /ml, produced by Pars Behruzan Jam Company, as a muscle injection, within 6 weeks. Intervention 2: Control group: Injection of 6 ampoules of Dexpanthenol 250 mg / 2 ml, produced by Bayer Company, as a muscle injection, within 6 weeks+ Injection of 6 ampoules of Biotin 5 mg /ml, produced by Bayer Company, as a muscle injection, within 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Aniseh Samadi
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 aniseh_samadi@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 7921 firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Male or female aged 18-55 years diffuse and scattered hair loss General health Voluntary participation and signing written informed consent 18 years 55 years Both Pregnancy or breastfeeding Chronic active scalp disease other than hair loss Using any prescribed drug or OTC for hair loss within the past 3 months People with allergies to drug ingredients Any severe weight loss or strict diet therapy during the study L65.9 Nonscarring hair loss, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Injection of 6 ampoules of Dexpanthenol 250 mg / 2 ml, produced by Pars Behruzan Jam Company, as a muscle injection, within 6 weeks+Injection of 6 ampoules of Biotin 5 mg /ml, produced by Pars Behruzan Jam Company, as a muscle injection, within 6 weeks Control group: Injection of 6 ampoules of Dexpanthenol 250 mg / 2 ml, produced by Bayer Company, as a muscle injection, within 6 weeks+ Injection of 6 ampoules of Biotin 5 mg /ml, produced by Bayer Company, as a muscle injection, within 6 weeks Hair lost Changes, based on Global photographic review. Timepoint: Before intervention, 1 and 8 weeks after last injection. Method of measurement: One independent dermatologist will perform clinical assessments in a blinded fashion by scoring every photograph according to the Global photographic review scale . Hair count changes. Timepoint: Before intervention, 1 and 8 weeks after last injection. Method of measurement: Dermatoscopy By Fotofinder. Changes in percentage of anagen to telogen. Timepoint: Before intervention, 1 and 8 weeks after last injection. Method of measurement: Dermatoscopy By Fotofinder. Pars Behruzan Jam Company Approved 2020-05-07 Ethics committee of Tehran University of Medical Sciences Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)